Senior Quality Assurance Specialist

4 weeks ago

London, United Kingdom Northreach Full time

Job Description

Northreach is a recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide clients and candidates with a seamless and personalised recruitment experience and create a positive work environment that encourages equality, innovation, and professional growth.

What will you be doing?

  • Works within established processes, guidelines and methods ensuring quality guidelines are adhered to
  • Support in routine QA duties to ensure manufacturing and testing activities comply with the local GMP facility processes where products are manufactured
  • Day to day responsibilities include the following elements of the PQS relating to manufacture and testing of cellular therapies including;
  • Document control system, Training system, Change controls
  • Corrective and preventative actions (CAPA)
  • Deviation & OOS reporting
  • Quality risk management
  • Participating in internal audits
  • Vendor qualification
  • Batch record review prior to QP release
  • Maintaining product specification files for ATIMP’s
  • Participates in risk assessment and investigations as required
  • Draft, review and approve Quality and GxP related documentation
  • Provides advice and guidance to the Quell manufacturing and QC teams on Quality related issues
  • Assists in the generation of quality metrics
  • Highlights quality related matters or risks to others that could impact product quality, product release or regulatory compliance.
  • Provides general quality support for other functions within the business e.g. R&D / clinical trial sample testing / process development teams as required
  • Promote quality culture and one of continuous improvement within team

What are we looking for?

  • Min 2 years’ experience or equivalent experience working in a Quality Assurance role in a GMP environment
  • Experience in providing pragmatic quality advice to manufacturing and quality control functions
  • Experience writing and reviewing GxP documents (including SOPs) to ensure good documentation, data integrity, GxP, quality and regulatory requirements are met.
  • Working knowledge of GMP relating to sterile production, cleanrooms, aseptic technique and hygienic requirements for sterile products is desirable
  • A working knowledge of regulatory requirements or processes that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s is required
#J-18808-Ljbffr

  • Quality Assurance Specialist

    4 weeks ago

    London, United Kingdom Centre People Full time

    A beauty and health food company is looking for a Quality Assurance Specialist to join their team in London. The Quality Assurance Specialist will be responsible for liaising with suppliers in Europe, America, Canada, Japan, and other various locations. Understanding of Japanese culture would be advantageous for this role. Experience in quality assurance/...

  • Senior Quality Assurance Specialist

    1 week ago

    London, United Kingdom BioTalent Full time

    Myself and BioTalent have partnered up with a pioneering biotechnology company focused on developing novel cell and gene therapies, on their search for a Senior Clinical QA Specialist based at their London site.For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on.As a Senior Clinical QA Specialist...

  • Senior Quality Assurance Specialist

    3 weeks ago

    London, United Kingdom BioTalent Full time

    Myself and BioTalent have partnered up with a pioneering biotechnology company focused on developing novel cell and gene therapies, on their search for a Senior Clinical QA Specialist based at their London site. As a Senior Clinical QA Specialist you will be responsible for ensuring the integrity and compliance of clinical trial operations and provide...

  • Senior Quality Assurance Specialist

    1 week ago

    London, United Kingdom BioTalent Full time

    Job DescriptionMyself and BioTalent have partnered up with a pioneering biotechnology company focused on developing novel cell and gene therapies, on their search for a Senior Clinical QA Specialist based at their London site.As a Senior Clinical QA Specialist you will be responsible for ensuring the integrity and compliance of clinical trial operations and...

  • Senior Quality Assurance Specialist

    3 weeks ago

    London, United Kingdom BioTalent Full time

    Myself and BioTalent have partnered up with a pioneering biotechnology company focused on developing novel cell and gene therapies, on their search for a Senior Clinical QA Specialist based at their London site. As a Senior Clinical QA Specialist you will be responsible for ensuring the integrity and compliance of clinical trial operations and provide...

  • Senior Quality Assurance Specialist

    3 weeks ago

    London, United Kingdom BioTalent Full time

    Myself and BioTalent have partnered up with a pioneering biotechnology company focused on developing novel cell and gene therapies, on their search for a Senior Clinical QA Specialist based at their London site.As a Senior Clinical QA Specialist you will be responsible for ensuring the integrity and compliance of clinical trial operations and provide...

  • Senior Quality Assurance Specialist

    23 hours ago

    London, United Kingdom BioTalent Full time

    Myself and BioTalent have partnered up with a pioneering biotechnology company focused on developing novel cell and gene therapies, on their search for a Senior Clinical QA Specialist based at their London site.For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on.As a Senior Clinical QA Specialist...

  • Quality Assurance Specialist

    2 weeks ago

    London, United Kingdom Elite Associates Full time

    Elite have partnered with a luxury fashion house, who are looking for a Quality Assurance Specialist to join their team. Job Description: The brand are seeking a detail-oriented and experienced Quality Assurance Specialist to join their luxury fashion brand. The ideal candidate will be responsible for ensuring the quality and integrity of our products...

  • Quality Assurance Specialist

    2 weeks ago

    London, United Kingdom Elite Associates Full time

    Elite have partnered with a luxury fashion house, who are looking for a Quality Assurance Specialist to join their team. Job Description: The brand are seeking a detail-oriented and experienced Quality Assurance Specialist to join their luxury fashion brand. The ideal candidate will be responsible for ensuring the quality and integrity of our products...

  • Quality Assurance Specialist

    2 weeks ago

    London, United Kingdom Elite Associates Full time

    Elite have partnered with a luxury fashion house, who are looking for a Quality Assurance Specialist to join their team.Job Description:The brand are seeking a detail-oriented and experienced Quality Assurance Specialist to join their luxury fashion brand. The ideal candidate will be responsible for ensuring the quality and integrity of our products meet the...

  • Quality Assurance Specialist

    4 weeks ago

    London, United Kingdom Quanta Full time

    Quality Assurance Specialist - Contract - London - Pharmaceuticals Our global Pharmaceutical client based in London is searching looking for two Quality Assurance Specialists to join their team, initially on a 6 month contract basis. This exciting and global client helps to transform the lives of millions of both human & animal patients in the UK by...

  • Quality Assurance Specialist

    1 week ago

    London, United Kingdom Elite Associates Full time

    Elite have partnered with a luxury fashion house, who are looking for a Quality Assurance Specialist to join their team.Apply (by clicking the relevant button) after checking through all the related job information below.Job Description:The brand are seeking a detail-oriented and experienced Quality Assurance Specialist to join their luxury fashion brand....

  • Quality Assurance Specialist

    1 week ago

    London, United Kingdom Elite Associates Full time

    Job DescriptionElite have partnered with a luxury fashion house, who are looking for a Quality Assurance Specialist to join their team.Job Description:The brand are seeking a detail-oriented and experienced Quality Assurance Specialist to join their luxury fashion brand. The ideal candidate will be responsible for ensuring the quality and integrity of our...

  • Quality Assurance Specialist

    6 hours ago

    London, United Kingdom Elite Associates Full time

    Elite have partnered with a luxury fashion house, who are looking for a Quality Assurance Specialist to join their team.Apply (by clicking the relevant button) after checking through all the related job information below.Job Description:The brand are seeking a detail-oriented and experienced Quality Assurance Specialist to join their luxury fashion brand....

  • Senior Quality Assurance Specialist

    3 weeks ago

    London Area, United Kingdom BioTalent Full time

    Myself and BioTalent have partnered up with a pioneering biotechnology company focused on developing novel cell and gene therapies, on their search for a Senior Clinical QA Specialist based at their London site.As a Senior Clinical QA Specialist you will be responsible for ensuring the integrity and compliance of clinical trial operations and provide...

  • Senior Quality Assurance Specialist

    3 weeks ago

    London Area, United Kingdom BioTalent Full time

    Myself and BioTalent have partnered up with a pioneering biotechnology company focused on developing novel cell and gene therapies, on their search for a Senior Clinical QA Specialist based at their London site.As a Senior Clinical QA Specialist you will be responsible for ensuring the integrity and compliance of clinical trial operations and provide...

  • Senior Quality Assurance Specialist

    3 weeks ago

    London Area, United Kingdom BioTalent Full time

    Myself and BioTalent have partnered up with a pioneering biotechnology company focused on developing novel cell and gene therapies, on their search for a Senior Clinical QA Specialist based at their London site.As a Senior Clinical QA Specialist you will be responsible for ensuring the integrity and compliance of clinical trial operations and provide...

  • Senior Quality Assurance Specialist

    3 weeks ago

    London Area, United Kingdom BioTalent Full time

    Myself and BioTalent have partnered up with a pioneering biotechnology company focused on developing novel cell and gene therapies, on their search for a Senior Clinical QA Specialist based at their London site. As a Senior Clinical QA Specialist you will be responsible for ensuring the integrity and compliance of clinical trial operations and provide...

  • Quality Assurance Specialist

    4 weeks ago

    London, United Kingdom CK Group Full time

    **Salary**:£15.00 to £25.90 ph paye - **REF Number**:00055940 - **Consultant**:Julie Marshall - **Contact**:01438 842964 - **Date Published**:10.08.2023 - **Sector**:Pharmaceutical - **Location**:London, London - **Discipline**:Quality CK Group are recruiting for a Quality Assurance Specialist to join a biopharmaceutical company at their site based in...

  • Quality Assurance Specialist

    2 weeks ago

    London Area, United Kingdom Elite Associates Full time

    Elite have partnered with a luxury fashion house, who are looking for a Quality Assurance Specialist to join their team.Job Description:The brand are seeking a detail-oriented and experienced Quality Assurance Specialist to join their luxury fashion brand. The ideal candidate will be responsible for ensuring the quality and integrity of our products meet the...