Quality Assurance Manager
2 days ago
At West Pharmaceutical Services, Inc., we're a dedicated team that's connected by a purpose to improve patient lives. Our story began with Herman O. West, who solved the problem of supplying penicillin in mass quantities during World War 2. Today, we deliver life-saving and life-enhancing injectable medicines to millions of patients daily.
We believe in giving back to help those in need in the communities where we live and work. We're equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary:
The Director of Regulatory Compliance will lead internal audits and participate in external audits and regulatory inspections. They'll ensure all products and processes comply with relevant regulations and guidelines, such as FDA, EMA, and MHRA.
- Develop, implement, and maintain the Quality Management System (QMS) in compliance with GMP, regulatory requirements, and company policies.
- Oversee the management of SOPs, Work Instructions, and other quality-related documentation.
Audits and Inspections:
- Lead internal audits and participate in external audits and regulatory inspections.
- Prepare audit reports, manage corrective and preventive actions (CAPAs), and follow up on audit findings.
Training and Development:
- Develop and execute training programs for staff on quality-related topics to ensure compliance with regulatory requirements and company standards.
- Monitor the effectiveness of training programs and maintain training records.
Quality Control:
- Oversee the quality control processes, including raw material testing, in-process monitoring, and final product testing.
- Ensure all quality control activities are documented and carried out in accordance with established procedures.
Deviation and Change Control Management:
- Manage and investigate deviations, non-conformances, and product complaints.
- Oversee the change control process to ensure proper evaluation, approval, and implementation of changes in procedures, equipment, or processes.
Required Qualifications:
- Bachelor's degree or higher in Pharmacy, Chemistry, Biology, or a related field.
- A minimum of 5 years of experience in quality management within the pharmaceutical industry.
- In-depth knowledge of GMP, FDA, EMA, and other relevant regulatory requirements.
- Experience with QMS implementation and management.
Skills and Competencies:
- Strong leadership and team management skills.
- Excellent communication and interpersonal skills.
- Attention to detail and strong analytical skills.
- Ability to handle multiple tasks and prioritize effectively.
- Proficiency in risk management and problem-solving.
- Competency in using quality management software and tools.
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