Qualified Person

2 weeks ago


Merthyr Tydfil, Merthyr Tydfil, United Kingdom Simbec-Orion Full time

ABOUT US:


Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases.

Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.


With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives.

Because our goal is the same as theirs; to improve patients' lives.

THE ROLE:


We are looking for a Qualified Person to join our IMP Management Department where you will be responsible for assuring the quality of Investigational Medicinal Product (IMP) through performing final certification of the finished IMP.

Qualified Person oversight of the importation of finished IMP from approved countries for import. Will provide Good Manufacturing Process (GMP) expertise to colleagues and clients.

KEY ACCOUNTABILITIES:

  • Performs final QP certification of the finished IMP, including batch documentation reviews and visual inspection, ensuring compliance with any specific expectations for GMP as per the CTA and IMPD registered details.
  • QP Oversight of the importation of finished IMP from an approved country for import.
  • Creates and reviews Investigational Medicinal Product Dossiers (IMPDs).
  • Linemanage, and provide leadership, coaching, and mentoring to ensure effective people development.
  • Provides pharmaceutical input and advice on protocols, Clinical Trial Authorisations (CTAs) and Requests for Proposals (RFPs)/Requests for Information (RFIs).
  • Conduct supplier approval assessments and audits.
  • Works within and supports the continuous improvement of QMS, including writing/reviewing/approving SOPs, change controls, deviations, technical agreements, production records, and labels.
  • Proactively contributes to quarterly/annual review of the GMP Pharmaceutical Quality System.
  • Represents Simbec-Orion at meetings with clients and regulatory bodies.
  • Deputise for the Head of IMP Management and QA Pharmacist as required.

SKILLS REQUIRED:

ESSENTIAL:

- _ Eligible to act as a QP and be suitable for nomination to act under a Simbec's MIA(IMP)_
- _ Degree in Science Subject or overseas equivalent_
- _ Extensive experience working in a GMP environment_
- _ Extensive experience in dealing with clients, providing technical Chemistry, Manufacture and Controls (CMC) advice_
- _ Previous experience in dealing with inspections and audits_
- _ Excellent verbal and written communication, fluent in English_
- _ Experience as a Line Manager_

DESIRABLE:

- _ Medical or scientific qualification (MSc, PhD, PharmD or MD)_
- _ Previous experience as a Qualified Person_
- _ Auditing experience to Good Manufacturing Practice standards_
- _ Audit Qualification, e.g. IRCA (International Register of Certificated Auditors) accredited_
- _ Previous experience within a Clinical Trial environment_
- _ Experience in business development activities, including CMC advice and _participation in proposal development and bid-defence meetings_
- _ Previous experience in writing documents for regulatory submissions e.g. _Investigational Medicinal Product Dossiers (IMPDs)_
- _ Experience or good understanding of handling and preparation of Radiopharmaceuticals_
- _ Experience in analytical QC or Microbiology QC_

WHY YOU SHOULD JOIN US:
Simbec-Orion is growing fast.

To keep up with demand, we're looking for the best people, from all areas of clinical development, to join our team.

We're dedicated to bringing the latest advances in science to market.

Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.

With experts from all disciplines under the same roof, you'll work alongside some of the industry's best.

So if you'd like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services.

We're waiting to hear from you.

  • Merthyr Tydfil, Merthyr Tydfil, United Kingdom Rodericks Dental Partners Full time

    Role DescriptionDo you have the right skills and experience for this role Read on to find out, and make your application.Vacancy Details:Newly Qualified Dentist OpportunityFD+1 schemeFlexible days and hours to suitNegotiable UDA targetWho we are:Rodericks Dental is an expanding and dynamic group of dental practices, offering NHS and Private care throughout...


  • Merthyr Tydfil, Merthyr Tydfil, United Kingdom Cwm Taf Morgannwg University Health Board Full time

    You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac The post holder will be required to implement packages of care devised by qualified Nurses/Therapists involving direct and non-direct care for the benefit of the patient on an individual or group setting....

  • Kitchen Cook

    2 weeks ago


    Merthyr Tydfil, Merthyr Tydfil, United Kingdom KHEHRA HOSPITALITY GROUP Full time

    An experienced, qualified, and creative cook is required to produce freshly prepared meals using fresh local produce. We are a small friendly team of owners and staff and need a flexible chef who can cope with variable numbers of covers for lunches and dinners. weekend work is required. Shifts negotiable.You will be responsible for the kitchen's daily...

  • People Advisor

    2 weeks ago


    Merthyr Tydfil, Merthyr Tydfil, United Kingdom TristoneNash Ltd Full time

    TristoneNash are pleased to be working with a Housing Association in South Wales to appoint a People Advisor for a 6-month fixed-term contract.This is a full-time contract, offering a 4-day working week and hybrid working (2 days per week in the office, 2 days WFH).Role and Requirements: Your role will be to provide an efficient and professional Human...


  • Merthyr Tydfil, Merthyr Tydfil, United Kingdom Noble Futures Childcare Ltd Full time

    We are expanding and looking for individuals to make a difference to young peoples lives, to help develop their opportunities and future prospects, to help turn their lives around. Working a family life friendly shift rota, well above average wage, company benefits, pension scheme options.We are a forward thinking organisation, developing staff as well as...


  • Merthyr Tydfil, Merthyr Tydfil, United Kingdom Cwm Taf Morgannwg University Health Board Full time

    We provide healthcare services to people living in Bridgend, Merthyr Tydfil and Rhondda Cynon Taf county borough areas, serving a population of around 450,000. We are ideally situated between Wales's capital city, Porthcawl to the west, and the stunning scenery in the Brecon Beacons.Our vision is to care for our communities and patients by preventing...

  • Psv Driver

    2 weeks ago


    Merthyr Tydfil, Merthyr Tydfil, United Kingdom BikePark Wales Full time

    Looking for something different? No late nights, early mornings, no overnights, no soul crushing traffic jams BikePark Wales offers a great opportunity to join a fun, unique environment that encourages you to have fun Job Title: PSV Bus Driver (D1 or D or DE) Supervisory: None Pay: Starting from £12.50 Reporting To: Transport management teamYou will be...

  • Uplift Supervisor

    2 weeks ago


    Merthyr Tydfil, Merthyr Tydfil, United Kingdom BikePark Wales Full time

    Looking for something different? No late nights, early mornings, no overnights, no soul crushing traffic jams BikePark Wales offers a great opportunity to join a fun, unique environment that encourages you to have fun Job Title: PSV Bus Driver (D1 or D or DE) Supervisory: None Pay: Starting from £ £13.50 per hour Reporting To: Transport managerYou will be...


  • Merthyr Tydfil, Merthyr Tydfil, United Kingdom Noble Futures Childcare Ltd Full time

    We are expanding and looking for experienced individuals who are ideally registered with Social Care Wales to make a difference to young peoples lives, to help develop their opportunities and future prospects, to help turn their lives around. Working a family life friendly shift rota, well above average wage, company benefits, pension scheme options.We are a...

  • Gweithiwr Priffyrdd

    2 weeks ago


    Merthyr Tydfil, Merthyr Tydfil, United Kingdom Merthyr Tydfil County Borough Council Full time

    Job:Gweithiwr Priffyrdd / Highways Operative**:Job Ref:RE-1477**:Salary:£22, To: £24,496.00**:Job Scale:Gradd 3 / Grade 3**:Job Hours:37 Awr / 37 Hours**:Location:Neighbourhood Services, Highways Department, The Basin, Abercynon, Mountain Ash, CF45 4RR**:Speciality:To provide effective, efficient, responsive and high quality highway maintenance service in...


  • Merthyr Tydfil, Merthyr Tydfil, United Kingdom Cwm Taf Morgannwg University Health Board Full time

    An opportunity has arisen for a keen, enthusiastic nurse to work as part of Bridgend south CMHT. The post is at band 6 and, the successful applicant will work with a multi-disciplinary team. The successful applicant will be the care coordinator for a caseload of patients and work within the framework of the Mental Health Measures Wales providing specialist...


  • Merthyr Tydfil, Merthyr Tydfil, United Kingdom Cwm Taf Morgannwg University Health Board Full time

    An opportunity has arisen for a keen and enthusiastic occupational therapist to work as part of Bridgend south CMHT. The post is at band 6 and, the successful applicant will work as part of the multi disciplinary team. You will be care coordinator for a caseload of patients and work within the framework of the Mental Health Measures Wales providing...

  • Family Solicitor 4PQE

    2 weeks ago


    Merthyr Tydfil, Merthyr Tydfil, United Kingdom Simpson Judge Ltd Full time

    Job Title: Exciting Opportunity for a Family Solicitor with 2-5PQE in Aberdare Location: Office-based in Aberdare, with some flexibility for remote work Salary: Around £45,000 Hours: Full-time position, 35 hours per week. Part-time options also available, working 3-4 days a week with flexible hours THE COMPANY: An established Law Firm with a strong...


  • Merthyr Tydfil, Merthyr Tydfil, United Kingdom Merthyr Tydfil County Borough Council Full time

    Job:Gweithiwr Priffyrdd Prentis / Apprentice Highways Operative**:Job Ref:APP-011**:Salary:Job Scale:NMW**:Job Hours:37 Awr / 37 Hours**:Location:Is-adran Priffyrdd, Uned 5 / Highways Division, Unit 5**:Speciality:NATIONAL MINIMUM WAGETo provide effective, efficient, responsive and high quality highway maintenance service in highways. To work in a...


  • Merthyr Tydfil, Merthyr Tydfil, United Kingdom Cwm Taf Morgannwg University Health Board Full time

    Job summary Working as a HCSW on the Respiratory ward you will be assisting patients with all activities of daily living including washing, dressing, feeding, toileting and pressure area care. You will be working under the direction of a registered nurse and the wider Multi Disciplinary Team. Main duties of the job The post holder will be required to...


  • Merthyr Tydfil, Merthyr Tydfil, United Kingdom Marston Holding Limited Full time

    Vacancy ID: Town: Merthyr Tydfil Closing Date: 15Feb2023 Salary:- £19,831.50Home-Based Customer Service Agent- £19, Marston Holdings Limited has an exciting opportunity for a Home-Based Customer Service Agent to join their team on a full time, permanent basis. As a Customer Service Agent with Marston Holdings Ltd you will have a pivotal role in our contact...


  • Merthyr Tydfil, Merthyr Tydfil, United Kingdom Sanctuary Personnel Ltd Full time

    Looking to take your nursing career to new heights? Look no further than Sanctuary Personnel, an esteemed and award-winning recruitment agency. With a TrustPilot score of 4.8/5 and over 500+ reviews, we are dedicated to connecting with talented healthcare professionals like you. We have an exciting locum opportunity for a Band 5/6Registered Perioperative...


  • Merthyr Tydfil, Merthyr Tydfil, United Kingdom Welsh Ambulance NHS Trust Full time

    Job summary The post holder is primarily employed to provide emergency repairs and routine maintenance of the NHS Trust's fleet of over 700 emergency and non-emergency vehicles. The ability to speak Welsh is desirable for this post; English and/or Welsh speakers are equally welcome to apply. Main duties of the job The post holder is required to...

  • Qualified Person

    2 months ago


    Merthyr Tydfil, United Kingdom Simbec-Orion Full time

    ABOUT US: Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team. With a focus on...

  • Personal Secretary

    4 weeks ago


    Merthyr Tydfil, United Kingdom Cwm Taf Morgannwg University Health Board Full time

    The Radiology Service is looking to appoint an enthusiastic and suitably qualified Personal Secretary who will support the running of the department.The successful applicant will have the opportunity to gain a wide variety of experience working to support Consultants and other professionals within the Radiology Department. You will need excellent...

  • Qualified Bus Driver

    4 weeks ago


    Merthyr Tydfil, United Kingdom Stagecoach Full time

    Salary PCV licence Holder We are looking for qualified bus drivers / PCV license holders to join our Merthyr Team Hourly Rate - £11.00 Per Hour Duties After 20:30 - £12.50 Per Hour Sunday Rate £15.50 new starter incentive paid weekly ** £1000** Payment is paid weekly not in one Payment Guaranteed 39 hours minimum hours if looking for full-time...


  • Merthyr Tydfil, United Kingdom PureGym Full time

    Personal Trainer/Fitness Coach - Merthyr Tydfil Merthyr Tydfil CF48, UK Req #12459 09 May 2024 Join the UK’s number one fitness brand and favourite gym. PureGym is the number 1 gym operator in the UK and growing at an unrivalled scale, providing more opportunities to join our fitness team as a Level 3 qualified Personal Trainer/Fitness Coach...


  • Merthyr Tydfil, United Kingdom PureGym Full time

    Personal Trainer/Fitness Coach - Merthyr Tydfil Merthyr Tydfil CF48, UK Req #12459 09 May 2024 Join the UK’s number one fitness brand and favourite gym. PureGym is the number 1 gym operator in the UK and growing at an unrivalled scale, providing more opportunities to join our fitness team as a Level 3 qualified Personal Trainer/Fitness Coach...


  • Merthyr Tydfil, United Kingdom PureGym Full time

    Personal Trainer/Fitness Coach - Merthyr Tydfil Merthyr Tydfil CF48, UK Req #12459 08 June 2024 Join the UK’s number one fitness brand and favourite gym. PureGym is the number 1 gym operator in the UK and growing at an unrivalled scale, providing more opportunities to join our fitness team as a Level 3 qualified Personal Trainer/Fitness Coach...


  • Merthyr Tydfil, United Kingdom Stagecoach Full time

    Salary Late night Driver We are looking for qualified bus drivers / PCV license holders to join our Merthyr team for our late roster £11.00 per hour Hourly Rate - £11.00 Per Hour Duties After 20:30 - £12.50 Per Hour Sunday Rate £15.50 £15.00 Overtime Rate new starter incentive paid weekly ** £1000** Payment is paid weekly not in One Payment. -...

  • Support Worker

    1 month ago


    Merthyr Tydfil, United Kingdom HAYS Full time

    Support Worker - Full time - Merthyr Tydfil Your new company We are looking to recruiting personable, flexible and motivated support workers to support our qualified staff with the delivery of care to our patients. You will be involved in meeting the psychological needs of a diverse group of service users with varying degrees of mental and physical issues....

  • Support Worker

    4 weeks ago


    Merthyr Tydfil, United Kingdom HAYS Full time

    Support Worker - Full time - Merthyr Tydfil Your new company We are looking to recruiting personable, flexible and motivated support workers to support our qualified staff with the delivery of care to our patients. You will be involved in meeting the psychological needs of a diverse group of service users with varying degrees of mental and physical issues....


  • Merthyr Tydfil, United Kingdom HAYS Full time

    Support Worker - Full time - Merthyr Tydfil Your new company We are looking to recruiting personable, flexible and motivated support workers to support our qualified staff with the delivery of care to our patients. You will be involved in meeting the psychological needs of a diverse group of service users with varying degrees of mental and physical issues....


  • Merthyr Tydfil, United Kingdom Cwm Taf Morgannwg University Health Board Full time

    You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac The post holder will be required to implement packages of care devised by qualified Nurses/Therapists involving direct and non-direct care for the benefit of the patient on an individual or group setting....

  • Scaffolder

    7 days ago


    Merthyr Tydfil, United Kingdom Indigo Group Services Full time

    **CALL 02920 022480 TO APPLY** BMSL Group needs Part 2 Qualified Scaffolders for a project in Clevedon. Duties will include Strip and Erect for modifications on a highways. You will need to have a valid CSCS card. £20.00 - £21.00 p/hr Monday to Friday, 7.30am - 5pm Start Date: As soon as possible Please get in touch via this advert if you are...


  • Merthyr Tydfil, United Kingdom Noble Futures Childcare Ltd Full time

    Do you want to make a difference to the lives of young people? To help develop their opportunities and future prospects? To help turn their lives around? Working a family life friendly shift rota, above average wage, company benefits and pension scheme options. We are a forward thinking organisation, developing staff as well as young persons, Career...


  • Merthyr Tydfil, United Kingdom Noble Futures Childcare Ltd Full time

    Do you want to make a difference to the lives of young people? To help develop their opportunities and future prospects? To help turn their lives around? Working a family life friendly shift rota, above average wage, company benefits and pension scheme options. We are a forward thinking organisation, developing staff as well as young persons, Career...


  • Merthyr Tydfil, United Kingdom Noble Futures Childcare Ltd Full time

    We are expanding and looking for individuals to make a difference to young peoples lives, to help develop their opportunities and future prospects, to help turn their lives around. Working a family life friendly shift rota, well above average wage, company benefits, pension scheme options. We are a forward thinking organisation, developing staff as well as...


  • Merthyr Tydfil, United Kingdom Noble Futures Childcare Ltd Full time

    We are expanding and looking for individuals to make a difference to young peoples lives, to help develop their opportunities and future prospects, to help turn their lives around. Working a family life friendly shift rota, well above average wage, company benefits, pension scheme options. We are a forward thinking organisation, developing staff as well as...


  • Merthyr Tydfil, United Kingdom Noble Futures Childcare Ltd Full time

    We are expanding and looking for individuals to make a difference to young peoples lives, to help develop their opportunities and future prospects, to help turn their lives around. Working a family life friendly shift rota, well above average wage, company benefits, pension scheme options. We are a forward thinking organisation, developing staff as well as...


  • Merthyr Tydfil, United Kingdom Noble Futures Childcare Ltd Full time

    We are expanding and looking for individuals to make a difference to young peoples lives, to help develop their opportunities and future prospects, to help turn their lives around. Working a family life friendly shift rota, well above average wage, company benefits, pension scheme options. We are a forward thinking organisation, developing staff as well as...

  • Nursery Practitioner

    3 weeks ago


    Merthyr Tydfil, United Kingdom Funtazia Day Nursery Full time

    Nursery Practitioner required for busy day nursery, must be qualified to level 2 or 3 in childcare, Immediate start, 38 hours per week, in between the hours of 7.30-6 pm Monday - Friday, must be willing to continue with professional development, must be passionate about working with children, DBS required unless on update system. Please note a teaching...


  • Merthyr Tydfil, United Kingdom TYDFIL TRAINING Full time

    **Assessor in Construction** Tydfil Training is an established provider of employability programmes, apprenticeships and training opportunities across many sectors. Are you passionate about helping to make a difference, creating positive life changing opportunities for individuals? Perhaps you are currently working within the construction industry and...