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Principal QA Advisor
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Location | East Anglia |
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Job Type | Permanent |
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Salary | £NEG |
Blackfield Associates are currently supporting a global CRO to recruit for a Senior / Principal QA Advisor to join the organisation on a permanent basis at their Cambridge site. Flexibility with hybrid working is available.
Responsibilities
As Senior/Principal QA Advisor you will be responsible to manage and execute a global supplier qualification program.
Key Responsibilities:
- Plan, coordinate, and manage the global supplier qualification program.
- Maintain and update the Global Supplier Database.
- Assess new suppliers based on risk-based criteria.
- Conduct periodic supplier assessments as per the established schedule.
- Monitor and report on supplier sustainability metrics.
- Lead meetings with high-risk suppliers and report on complaints or supplier issues.
- Participate in external audits related to supplier qualification and implement feedback for process improvements.
- Build and maintain strong relationships with suppliers, acting as the primary contact for external communications.
- Work with clients and internal teams to prepare and execute quality agreements.
- Maintain regulatory agency registrations (FDA, EMA, etc.) as required.
- Conduct study, process, and facility audits as needed.
- Stay updated on current regulations and guidance.
- Investigate and resolve supplier CAPAs (Corrective and Preventive Actions).
- Collaborate with QA and Operational teams to drive efficiencies across the group.
- Serve as the main contact for client quality agreements and regulatory registrations, ensuring accurate and current documentation.
Requirements
Skills, Education & Qualifications:
- Strong understanding and experience in GxP or ISO regulated environments.
- Demonstrable auditing skills, with experience in establishing audit scope and developing relevant audit schedules and checklists.
- Knowledge of Quality Management Systems (QMS) and experience supporting systems like Deviations, OOS, Change Control, and CAPA.
- Excellent communication skills with the ability to interact effectively with customers, suppliers, and regulators.
- Preferably experienced within the pharmaceutical industry.
- Minimum qualification: BSc in a scientific field, recognized auditor certification, or equivalent industry experience.
Apply
If this position interests you, and you would like to learn more or explore other available jobs that could also match your skill set, please apply today or email melissa@blackfieldassociates.com