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Quality Assurance Manager

2 months ago

Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom NHS Full time
Job Title: QA Validation Manager

We are seeking a highly motivated and experienced QA Validation Manager to join our Quality Assurance Team at Newcastle Specials. The successful candidate will be responsible for leading the validation of analytical methods, equipment, and computerized systems in accordance with Pharmaceutical Good Manufacturing Practice (GMP) guidelines.

Key Responsibilities:
  • Lead the development and implementation of validation protocols for analytical methods, equipment, and computerized systems.
  • Ensure compliance with GMP guidelines and regulatory requirements.
  • Collaborate with production and business teams to ensure timely delivery of projects and products.
  • Develop and maintain a validation master plan to ensure effective and efficient validation processes.
  • Provide training and support to Quality Control staff and others as required.
  • Lead the implementation of a risk-based approach to validation in accordance with our validation master plan.
  • Develop and maintain a comprehensive understanding of GMP, EU GMP Annex 15, and EU GMP Annex 11.
  • Lead the development and implementation of a harmonized validation approach within the Pharmaceutical Quality System.
  • Design and implement systems and protocols to optimize the utilization of personnel time and facilities.
  • Deliver a comprehensive and responsive validation service to the RVI and Freeman sites.
Requirements:
  • Relevant experience of working in a licensed pharmaceutical facility.
  • Audit of services by external auditing organization e.g. MHRA.
  • Managing or training staff.
  • Extensive theoretical and practical experience of audit and policy development in a range of settings to Masters level or equivalent.
  • Proven experience in a GMP environment and/or quality setting, including policy developments.
  • Ability to work strategically.
  • Policy design and implementation.
  • Trained in appraisal skills.
  • Degree with a scientific background.
  • Experience of quality management systems and methodologies.
  • Experience of preparing for external inspection.
  • Experience of monitoring compliance with national risk management/quality standards.
Knowledge and Experience:
  • Knowledge of Pharmaceutical Audits e.g. MHRA.
  • Knowledge of Good Manufacturing Practice (Rules & Guidance for Pharmaceutical Manufacturers and Distributors).
  • Knowledge of a Validation Master Plan within a pharmaceutical Quality System.
  • Application of health and safety and COSHH in pharmaceutical setting.
  • Experience of providing training.
  • Experience of executing validation protocols.
  • Knowledge of EU GMP Annex 15: Qualification and Validation.
  • Knowledge of EU GMP Annex 11: Computerised systems.
  • Knowledge of Quality Risk management approach to qualification and validation activities (ICH Q9).
  • Working knowledge of sterilisers for pharmaceutical applications.
  • Working knowledge of WFI systems.
  • Working knowledge of designs of various isolators types.
  • Experience of performing Validation protocols within a pharmaceutical GMP environment.
  • Experience of preparing validation documents within a Pharmaceutical GMP environment.
  • Experience of cleaning validation/verification.
  • Working knowledge of validation master plans and their application.
  • Working knowledge of QC analytical equipment and method validation.
Skills and Abilities:
  • Excellent interpersonal and communication skills.
  • Organisation and planning skills.
  • Leadership and management skills.
  • Negotiation, persuasion and problem-solving skills.
  • Project management skills and knowledge.
  • Research and audit skills.
  • Well-developed report writing and analytical and presentation skills.
  • Evidence of relevant continuous professional development.
  • Ability to lead meetings.
  • Counselling / mentoring.
  • Ability to manage change and meet deadlines.
  • Ability to collaborate effectively with cross-functional teams.
  • Strong attention to detail.
  • Interviewing / appraisal.
Disclosure and Barring Service Check:

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.