FPSG is working witha leading pharmaceutical company committed to delivering high-quality, life-saving medications to patients worldwide. We are currently seeking a dedicated and experienced Quality Assurance Manager to join our team in Oxford. This is an exciting opportunity to play a pivotal role in ensuring the safety, efficacy, and compliance of our pharmaceutical products.
Position Overview: As the Quality Assurance Manager, you will be responsible for overseeing all aspects of the quality management system to maintain regulatory compliance and uphold product quality standards. You will lead a team of QA professionals, implement quality processes, and drive continuous improvement initiatives across the organization.
Key Responsibilities:
1. Develop and maintain the company's Quality Management System (QMS) in accordance with regulatory requirements (e.g., GMP, GDP, GLP).
2. Lead and manage the QA team, providing guidance, training, and support to ensure effective execution of QA activities.
3. Conduct internal audits, supplier audits, and risk assessments to identify areas of non-compliance and implement corrective and preventive actions (CAPAs).
4. Review and approve documentation related to product manufacturing, testing, and release, including batch records, protocols, and reports.
5. Collaborate with cross-functional teams to ensure timely resolution of quality issues and deviations.
6. Lead regulatory inspections and customer audits, preparing the site and guiding staff through the audit process.
7. Implement quality metrics and Key Performance Indicators (KPIs) to monitor and improve quality performance.
8. Stay updated on current regulations, industry trends, and best practices in quality assurance and provide training to staff as needed.
Qualifications:
9. Bachelor's degree in Pharmacy, Chemistry, Biology, or related field. Advanced degree (MSc or PhD) is a plus.
10. Minimum of 5 years of experience in quality assurance within the pharmaceutical industry, with at least 2 years in a managerial or leadership role.
11. In-depth knowledge of GMP, GDP, GLP, and other relevant regulations and guidelines.
12. Experience leading and managing QA teams, with a strong understanding of quality systems and processes.
13. Proven track record of successful regulatory inspections and audits from regulatory authorities and customers.
14. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
15. Strong problem-solving skills, attention to detail, and ability to make sound decisions in a fast-paced environment.
16. Certification in Quality Management (e.g., Certified Quality Auditor, Certified Quality Manager) is desirable.
We are Disability Confident and neurodiverse aware. If you have a disability, please tell us if there are any reasonable adjustments we can make to assist you in your application or with your recruitment process
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