Qualified person
4 weeks ago
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
General Purpose of Role : To QP certify manufacturing processes/activities performed under PCI Pharma Services MHRA licences.
Main Responsibilities :
- To review Batch Manufacturing Documents to ensure compliance with UK and EU GMP and the Product Specification File/marketing authorisation (or other where relevant).
- To review Batch Documents for all operations performed at PCI Pharma Services (PCI).
- To certify Medicinal Products for use in the UK and EU and outside the EU (where relevant).
- To undertake audits in the UK, EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP
- To provide advice and guidance to PCI staff and Customers regarding QP requirements within the UK and EU.
- To keep up to date with the requirements of the Medicines Authorities across the UK, EU and rest of world (where relevant).
- To review PCI Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and PCI procedures.
- To provide input and assistance with relevant elements of the Quality Management System (QMS) at PCI.
- Assistance with regulatory inspections and client audits.
- Perform Supply Chain Oversight when required.
Specific Qualifications :
Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with UK legislation and EU directives 2001/83/EC and 2001/20/EC respectively.
Previous Work Experience :
Experience working as a QP in the certification of sterile medicinal products in particular Biopharmaceuticals manufactured aseptically.
Specific Knowledge / Skills Competence :
- Extensive QA experience within the medicinal products/ pharmaceutical industry.
- GMP Audit experience preferably qualified as Lead Auditor
- Experience in Biopharmaceuticals
- Experience in Sterile manufacture
- Effective Communication skills
- Good IT skills (at least MS Word).
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
-
Bgd qualified Person
6 months ago
Bridgend, United Kingdom PCI Pharma Services Full timeLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. General Purpose of Role: To QP certify...
-
Qualified person
2 months ago
Bridgend, United Kingdom PCI Pharma Services Full timeWe are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. General Purpose of Role: To QP certify manufacturing processes/activities performed under PCI Pharma Services MHRA licences.Main Responsibilities:To...
-
Qualified person
4 weeks ago
bridgend, wales, United Kingdom PCI Pharma Services Full timeWe are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. General Purpose of Role : To QP certify manufacturing processes/activities performed under PCI Pharma Services MHRA licences. Main Responsibilities...
-
Qualified person
2 months ago
Bridgend, Wales, Wales, United Kingdom PCI Pharma Services Full timeWe are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. General Purpose of Role: To QP certify manufacturing processes/activities performed under PCI Pharma Services MHRA licences.Main Responsibilities:To...
-
BGD_Qualified Person
6 months ago
Bridgend, United Kingdom PCI Pharma Services Full timeLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. General Purpose of Role : To QP...
-
Senior Residential Support Worker
6 months ago
Bridgend, United Kingdom Llamau Full time**Job description** **What we expect from you** - To provide young people aged 14 plus with excellent care and support within the home. Ensuring high levels of emotional and physical care, appropriate activities, as well as a comfortable, safe and supportive environment are provided to the young people who live within the home, - Support the young people to...
-
Newly Qualified Education Practitioner
6 months ago
Bridgend, United Kingdom Team Educate Full timeWe work with a range of schools in the Bridgend area that are in need of 1-to-1 support for their pupils, ranging from those with special educational or additional learning needs, to those who need emotional guidance and coaching. If you choose to work with our agency, you will play a vital role in allowing pupils to flourish, both personally and...
-
Accounts Assistant
6 months ago
Bridgend, United Kingdom Joanne Lewis Accountancy Full timeThe role is based in Bridgend, working with Joanne Lewis Accountancy Ltd, an established accountancy practice. **Overall Responsibilities** Assist Accountant with the preparation of management accounts, year-end accounts, tax returns for sole traders, partnerships and limited companies. Preparation of VAT returns. **Qualifications and Skills** Part...
-
Locum Social Work
20 hours ago
Bridgend, United Kingdom NonStop Consulting Full timeLocum Social Work - Short Term Team We're currently looking for a passionate and experienced Locum Social Worker to join our Adult Social Services Assessment Team on a locum basis in South Wales. This role offers a fantastic opportunity for a qualified Social Worker to play a key part in supporting vulnerable adults and making a meaningful impact in the...
-
Locum Social Work
4 weeks ago
Bridgend, United Kingdom CV-Library Full timeLocum Social Work - Short Term Team We're currently looking for a passionate and experienced Locum Social Worker to join our Adult Social Services Assessment Team on a locum basis in South Wales. This role offers a fantastic opportunity for a qualified Social Worker to play a key part in supporting vulnerable adults and making a meaningful impact in the...
-
Senior Accounting Expert
3 weeks ago
Bridgend, Bridgend county borough, United Kingdom Talent Tent Full timeAccounting Roles at Talent TentOur client, a leading accountancy practice in South Wales, is seeking a highly skilled Senior Accounting Expert to join their team. The ideal candidate will have extensive experience in accountancy, particularly in management accounting, personal tax, and business tax computations. The successful applicant will be responsible...
-
Accounts Lead
4 weeks ago
Bridgend, Bridgend county borough, United Kingdom Talent Tent Full timeThriving Bridgend-based practice accountants require a Senior Accountant to service a portfolio of clients.Responsibilities include management accounting, Personal Tax and Business Tax computations, and Accounts Preparation.The ideal candidate will have experience in an accountancy practice, ACCA/ ACA/ AAT qualification, and strong experience within a...
-
Trailer Fitter
5 months ago
Bridgend, United Kingdom John Raymond Transport Full time**At John Raymond Transport we are looking for a fully qualified Trailer Fitter to join our team in Bridgend.** **Key Responsibilities** - Diagnose and repair trailers, dealing with mechanical breakdowns and damage to restore vehicles to required performance in order to minimise/or avoid unnecessary delays. - Provide technical knowledge/advice/skill to...
-
Bridge to Global Health
2 weeks ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeLife-changing therapies. Global impact.We are PCI Pharma Services, a leading contract development and manufacturing organization (CDMO) dedicated to helping pharmaceutical companies bring their products to market.Our investment is in people who make an impact, drive progress, and create a better tomorrow. Our strategy includes building teams across our...
-
1:1 Aln Support Worker,
6 months ago
Bridgend, United Kingdom Suppleo Education Full timeSuppleo Education is a dedicated education recruitment agency who believe in building relationships on understanding and respect. We pride ourselves on providing an unparalleled quality of service to not only our schools but our staff too! A popular, leading school in Bridgend are on the hunt for a talented Male 1:1 ALN Support Worker for an immediate...
-
Kitchen Fitter
5 months ago
Bridgend, United Kingdom Collister North West Full timeTeam of kitchen fitters required to join our team to undertake work at a project in Bridgend to include 2nr tea point kitchens **Experience**: Minimum 3 years experience and be at least NVQ level 2 qualified or higher **Skills**:Will need to have a very good understanding of all aspects of kitchen fitting within general building and refurbishments. Will...
-
Mental Health Assistant
7 days ago
Bridgend, Bridgend county borough, United Kingdom Swansea Bay University Health Board Full timeIf you are passionate about delivering high-quality, person-centred care, we would like to hear from you. This role offers the opportunity to work in a dynamic and supportive team, contributing to the care and development of individuals accessing continuing healthcare services.You will be required to demonstrate empathy and compassion towards others, show...
-
Credit Control/accounts Assistant
5 months ago
Bridgend, United Kingdom Redwood Environmental Services Ltd Full time**About Us** Redwood Environmental Services is a family-run waste management and drainage company based in Bridgend. We cover all of South Wales and the UK and specialise in liquid waste removal, liquid waste treatment, drainage, survey, and inspections. Established in 2003, our dedicated team consists of qualified drainage and waste management specialists....
-
Paramedic Assessor
6 months ago
Bridgend, United Kingdom Donard Recruitment Full timeParamedic Assessor - Hybrid: Use your existing clinical knowledge to further your career and become a Disability Assessor! This is an opportunity for Qualified Nurses, Occupational Therapists, Paramedics and Physiotherapists to take on a new challenge with a leading, multinational organisation in a Remote working* role offering comprehensive training and...
-
Floor Fitter
5 months ago
Bridgend, United Kingdom Collister North West Full timeTeam of floor fitters required to join our team to undertake all aspects of flooring work at a project in Bridgend to include carpet, vinyl, patterned vinyl, nosings and trims. **Experience**: Minimum 3 years experience and be at least NVQ level 2 qualified or higher **Skills**:Will need to have a very good understanding of all aspects of flooring within...