QA Manager - GMP

  • Salary: £50,000 to £65,000 per annum
  • REF Number: 00052331
  • Consultant: Naynesh Mistry
  • Contact: 01246 457703
  • Date Published: 14.12.2021
  • Sector: Pharmaceutical, Biotechnology
  • Location: Oxford, Oxon/Wilts
  • Discipline: Quality

CK Group are recruiting for a highly experienced QA Manager to join an innovative biotech company. This will be an office based role in Oxford on a permanent basis with flexibility of home working. This role would be ideal for a candidate with strongexpertise in QMS within a GMP regulated environment.

The Company:

Excellent opportunity to join a small biotech with a focus in oncology.

The Role:

  • Provide operational support including maintenance of the GMP quality systems, both internal and through third parties, and to be a key member of the Quality Management Team.

Responsibilities

  • provide support to the Quality Team Leadership across a broad range of responsibilities, including:
  • Quality Management Systems (QMS) - contribute to the development and maintenance of QMS
  • Quality Assurance and Quality Control - develop and review quality project plans ensuring they run to schedule
  • Third Party Quality Assurance - support appropriate vendor selection and supplier qualification

Your Background:

  • Minimum BSc in a Chemistry, Biology, Pharmacy or related life science.
  • Experience in a GMP environment and managing GMP compliance activities.
  • GMP auditing experience.
  • Demonstrable experience in contributing to all clinical quality matters leading to regulatory submission, clinical protocols, conduct of clinical trials, according to all regulatory and GMP standards.
  • Experience of International GMP/ICH and clinical quality laws,regulations and guidelines.
  • Extensive experience in QMS and risk-based auditing within a pharmaceutical manufacturing organisation including experience in conducting an on-site audit of a vendor and clinical trial site.
  • Proven experience in GMP auditing associated with chemical API and excipient manufacturers and suppliers; packaging suppliers; and solid oral dosage form manufacturers
  • Experience providing internal consultation and training on quality systems and GCP.

Apply:

For more information or to apply for this position, please contact Naynesh Mistry on 01246 457703 or via email on nmistry@ckgroup.co.uk, quoting job ref 52331.

It is essential that applicants hold entitlement to work in the UK.nities are offered, skills are stretched, innovation is welcomed, and excellence is rewarded, you should consider a career with CK Group. We might be exactly what you're looking for.

Apply: Entitlement to work in the UK is essential. For more information or to apply for this Trainee Recruitment Consultant position, please email applications@ckgroup.co.uk. Please quote reference 52341.

INDRECher at conferences or seminars appropriate to the discipline.

  • Contribute to grant applications submitted by others.
  • Begin to write, with appropriate support, bids for individual research funding or, where funders do not permit this, contribute to the writing of collective bids.
  • Begin to referee papers for external bodies.
  • Participate effectively in activities to achieve engagement with research, and/or impact beyond academia.
  • Please note this list is not exhaustive, follow the link to view the full details

Criteria

Education, Experience & Achievements

Essential

  • A relevant postgraduate research degree or equivalent professional experience in the field of carbohydrate material science.
  • Previous experience of independent research.
  • Presentations at conferences and a track record of publications in respected journals or equivalent in the field.

Desirable

  • Research experience in polysaccharide and their industrial applications.
  • Involvementin packaging material research and development.
  • Materials formulation and characterisation expertise.

Skills & Knowledge

Essential

  • Demonstrable communication skills in English language.
  • Good IT skills in Microsoft/Adobe Programmes.
  • Excellent report writing and presentation skills.
  • Good time management and organisational skills.
  • Good interpersonal skills. Initiative in planning research.
  • Detailed subject knowledge in the area of research.
  • Specialist knowledge and practical skills capable of leading to independent, original contributions to the subject area.
  • High-level analytical skills.
  • Full awareness of the ethical issues involved in their research work.

Desirable

  • Project managementexperience.
  • Team working skills.
  • Communication skills.

Personal Attributes

Essential

  • Ability to communicate complex information clearly, both orally and in writing.
  • Ability to stimulate and encourage the commitment to learnin others.
  • Ability to use initiative, and apply creativity, to solve problems that

Desirable

  • A passion for making a positive impact on the environment especially in plastic waste.

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