Qualified person

4 weeks ago


bridgend wales, United Kingdom PCI Pharma Services Full time

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.


  • Qualified person

    2 months ago


    Bridgend, Wales, Wales, United Kingdom PCI Pharma Services Full time

    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...

  • Bgd qualified Person

    6 months ago


    Bridgend, United Kingdom PCI Pharma Services Full time

    Life 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 time

    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...

  • Qualified person

    4 weeks ago


    Bridgend, United Kingdom PCI Pharma Services Full time

    Job Description 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...

  • Personal Tax

    1 week ago


    Wales, Swansea, Swansea, Wales, United Kingdom Hays Accountancy and Finance Full time

    Your new companyA leading local firm of Chartered Accountants and Tax Specialists looking for either a Fully Qualified or Part Qualified Accountant looking to specialise within personal tax. This is an excellent opportunity for someone who is AAT, QBE or part ACA/ACCA/CTA qualified looking to specialise. They are open to candidates from a variety of...

  • BGD_Qualified Person

    6 months ago


    Bridgend, United Kingdom PCI Pharma Services Full time

    Life 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...


  • 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...

  • Electrician - HV

    2 weeks ago


    bridgend, wales, United Kingdom CRG TEC Full time

    Electrician - HV- £37k - £45k & van, overtime, fuel card & 23 day holiday, life cover, all expenses covered (food, accommodation etc.)- Permanent, career focused role- Industrail experiance essential - UK wide projects - so travel is essentialOverview:Are you an electrical professional who has hit a glass ceiling where you are? Maybe sick of doing subbie...


  • Bridgend, United Kingdom Team Educate Full time

    We 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...


  • bridgend, wales, United Kingdom Morwell Talent Solutions Full time

    Senior Management Accountant requiredSouth WalesSalary of up to £65,000 per annum plus excellent benefits package Mrwell Talent Solutions is delighted to be partnering on an exclusive basis with a market leading FMCG business in South Wales. Our client has enjoyed significant growth in recent years which has been facilitated by increased customer demand,...


  • Wales, United Kingdom TAZROCK LTD Full time

    Tazrock require a fully qualified and experienced QUARRY PLANT OPERATIVES. Multiskilled operatives would be ideal for this role. For various sites around the UK Experience in the quarry industry is an advantage. Must have a CPCS blue card. Loading shovel. 360 excavator. ADT. Due to the nature of our work applicants must be willing to work away as and...


  • Wales, United Kingdom Academics Ltd Full time

    Art and Design Teacher Job DescriptionWe are seeking a qualified Art and Design teacher to join our team at Academics Ltd. The successful candidate will be responsible for teaching 'mature' pupils in a supportive and ambitious setting.Key Responsibilities:Plan and prepare effective schemes of learning and lessonsUse innovative and diverse teaching methods...

  • Accounts Assistant

    6 months ago


    Bridgend, United Kingdom Joanne Lewis Accountancy Full time

    The 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...

  • Senior Accountant

    1 month ago


    Bridgend, Bridgend county borough, United Kingdom Talent Tent Full time

    As a Senior Accountant with Talent Tent, you will be part of a thriving Bridgend-based practice that has been operating for 21 years. Our company has seen significant portfolio growth, supplying admin and accountancy assistance to businesses throughout South Wales.The role involves serving a portfolio of clients with management accounting, Personal Tax, and...

  • Locum Social Work

    4 weeks ago


    Bridgend, United Kingdom CV-Library Full time

    Locum 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...


  • Bridgend, Bridgend county borough, United Kingdom Talent Tent Full time

    Accounting 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 time

    Thriving 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...


  • Wales, United Kingdom Academics Ltd Full time

    Science Educator PositionWe are seeking a dedicated and passionate Science Educator to join our team at Academics Ltd. As a Science Educator, you will be responsible for planning and preparing effective schemes of learning and lessons that support the national curriculum. You will use innovative and diverse teaching methods to engage students and promote...

  • General Supply Teacher

    3 months ago


    wales, United Kingdom Academics Ltd Full time

    Are you irritated with the lack of regular and consistent supply work that impacts your weekly income?Are you a qualified teacher looking to work in excellent academic secondary schools where there's no preparing, planning and marking involved? Are you qualified teacher looking for stress-free and flexible schedule to explore other life pursuits? Teaching is...

  • 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...