BGD_Qualified Person in Bridgend

1 month ago


Bridgend, United Kingdom PCI Pharma Services Full time

Job Reference: JR110661

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 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).


  • BGD_Qualified Person

    4 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...

  • Receptionist

    3 months ago


    Bridgend, United Kingdom Bridgend Ford Full time

    We are a family-run business based in Bridgend that has proudly served the community since 1986. Bridgend Ford is one of South Wales’s largest privately-owned Ford Main Dealers. With an exemplary reputation we are constantly striving to provide the best service in the industry. We pride ourselves on delivering an excellent experience along with building...


  • Bridgend, United Kingdom MGH Consultancy Ltd Full time

    Job Title: FUNDRAISER Bridgend Experienced Fundraiser for Bridgend, top rates, must drive We are looking for mature experienced fundraisers to work in Bridgend and surrounding areas to carry out charity bucket collections Promotion and Good Sales people also considered any age must drive. Thank you for your interest in joining our team! **Job Types**:...

  • Senior Practitioner

    2 months ago


    Bridgend, United Kingdom Bridgend County Borough Council Full time

    Contractual Hours: 37 hours per week Basis: Full time Job Reference: 16496 The Kinship and Permanence Team in Bridgend assesses and supports Kinship Foster Carers and Special Guardians. The Senior Practitioner role is an exciting opportunity to be part of a fast paced, growing service supporting foster carers and...

  • Sales Administrator

    3 months ago


    Bridgend, United Kingdom Bassetts Citroen Bridgend Full time

    The Bassetts Group has grown to be one of the top 20 dealers in the UK today. We boast two Honda, three Citroen, one SsangYong and two Nissan dealerships spread across South and West Wales. Our Honda and Nissan dealerships are situated in Swansea and Bridgend, our Citroen dealerships are in Swansea, Carmarthen and Bridgend, and our SsangYong branch is in...

  • Painter in Bridgend

    1 month ago


    Bridgend, United Kingdom Kingston Barnes Ltd Full time

    Painters required in Bridgend, South Wales Construction Recruitment Specialists Kingston Barnes Ltd are currently recruiting for Painters in Bridgend, CF31 Starting Immediate FULL DETAILS = Project = Interior refurbishment of listed building Qualifications = Must have CSCS Card. Duration = 3 weeks Hours = Monday to Friday (10 hours Mon-Thurs, 8 hours...

  • Service Advisor

    3 months ago


    Bridgend, United Kingdom Bridgend Ford Full time

    **Bridgend Ford Service Advisor** We are a family-run business that has proudly served the community for over 35 years and constantly striving to provide the best customer service in the industry. The Service department has seen a huge growth in recent times and continues to increase; to maximise the opportunity of this growth, the business is looking for...


  • Bridgend, United Kingdom EweMove Bridgend West Full time

    **Summary**: We are looking for an Associate to join our team on a self-employed basis. EweMove Bridgend West is an award-winning, customer-focused, innovative, industry-leading Estate Agency. You will be the face of EweMove, establishing yourself as the 'go-to' person to provide property sales and lettings services. We are seeking a motivated and ambitious...


  • Bridgend, United Kingdom Aramark Full time

    Catering Stores Person / Driver - Bridgend, Bridgend (Pen-y-bont ar Ogwr) Job Types: Full-time, Permanent Pay: £12.50 per hour Your Aramark journey starts here Are you looking to work in a busy environment as part of a team? Do you have a CAT C1 Licence? Are you looking for a full time position, Monday - Friday only where no day is the same? We are...


  • Bridgend, United Kingdom Aramark Full time

    Catering Stores Person / Driver - Bridgend, Bridgend (Pen-y-bont ar Ogwr)Job Types: Full-time, PermanentPay: £12.50 per hourYour Aramark journey starts hereAre you looking to work in a busy environment as part of a team?Do you have a CAT C1 Licence?Are you looking for a full time position, Monday – Friday only where no day is the same?We are currently...

  • Cleaning Operative

    4 months ago


    Bridgend, United Kingdom Betterclean Services Bridgend Full time

    **Betterclean Services Bridgend **is hiring a cleaner operative to work at one of our site in Bridgend Industrial Estate. **Shifts** are flexible 3 days a week **Betterclean Services Bridgend **is a locally owned company, part of a national network, and we have proudly served commercial clients for over 25 years. **Your skills and experience** Experience...


  • Bridgend, United Kingdom Suppleo Education Full time

    Suppleo Education is an award-winning 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 teachers and support staff at all levels across Wales and England. **Job Specification** Role: Cleaner Rates from: £11.50 /...

  • Sales Administrator

    4 months ago


    Bridgend, United Kingdom Bridgend Ford Full time

    We are a family-run business based in Bridgend that has proudly served the community since 1986. Bridgend Ford is one of South Wales’s largest privately-owned Ford Main Dealers. With an exemplary reputation we are constantly striving to provide the best service in the industry. We pride ourselves on delivering an excellent experience along with building...

  • Care Assitant

    3 months ago


    Bridgend, United Kingdom Everycare Bridgend LTD Full time

    **Are you interested in helping Individual live independently in their own homes?** **Would you like to make a difference to their lives?** **Are you looking for a rewarding career?** Everycare Bridgend Ltd has been providing domiciliary care throughout the Borough of Bridgend and the surrounding areas for over 27 years, providing all aspects of support...

  • Health Care Assistant

    4 months ago


    Bridgend, United Kingdom Everycare Bridgend LTD Full time

    **Are you interested in helping Individual live independently in their own homes?** **Would you like to make a difference to their lives?** **Are you looking for a rewarding career?** Everycare Bridgend Ltd has been providing domiciliary care throughout the Borough of Bridgend and the surrounding areas for over 27 years, providing all aspects of support...

  • Support Worker

    2 weeks ago


    Bridgend, Bridgend county borough, United Kingdom Dimensions Full time

    Job Title: Support Worker - BridgendJob Type: Full-time, Part-time, ReliefLocation: BridgendAbout the Role:We are seeking an experienced Support Worker to join our team in Bridgend. As a Support Worker, you will play a vital role in providing high-quality care and support to individuals with complex needs.Key Responsibilities:Provide personal care and...

  • Support Worker

    3 weeks ago


    Bridgend, Bridgend county borough, United Kingdom Dimensions Full time

    Job Title: Support Worker - BridgendJob Type: Full-time, Part-time, ReliefLocation: BridgendAbout the Role:We are seeking an experienced Support Worker to join our team in Bridgend. As a Support Worker, you will play a vital role in providing high-quality care and support to individuals with complex needs.Key Responsibilities:Provide personal care and...


  • Bridgend, United Kingdom Aramark Full time

    Catering Stores Person / Driver - Coity, Bridgend Job Type: Full Time - Permanent Your Aramark journey starts here Are you looking to work in a busy environment as part of a team? Do you have a CAT C1 Licence? Are you looking for a full time position, Monday - Friday only where no day is the same? We are currently recruiting for a Multi Drop Catering...

  • Catering Stores Person

    2 months ago


    Bridgend, United Kingdom Aramark Full time

    Catering Stores Person / Driver - Coity, BridgendJob Type: Full Time - PermanentYour Aramark journey starts hereAre you looking to work in a busy environment as part of a team?Do you have a CAT C1 Licence?Are you looking for a full time position, Monday – Friday only where no day is the same?We are currently recruiting for a Multi Drop Catering Stores...


  • Bridgend, United Kingdom MGH Consultancy Ltd Full time

    Job Title: FUNDRAISER Experienced Fundraiser for Bridgend top rates, must drive We are looking for mature experienced fundraisers to work around Brigend and surrounding areas bucket collecting. Promotion and Good Sales people also considered any age must drive. Have you ever done this before if so call us asap. No sign ups Thank you for your interest in...