Pharmaceutical Quality Assurance Specialist

About the Role

Our client is seeking a meticulous and detail-oriented Pharmaceutical Quality Assurance Specialist to join their team in Milton Keynes . In this vital role, you will be responsible for ensuring that all pharmaceutical products manufactured and distributed meet the highest standards of quality, safety, and efficacy. You will play a key part in maintaining compliance with regulatory requirements, implementing quality management systems, and driving continuous improvement initiatives across the organization. This is an excellent opportunity to contribute to product integrity and patient safety within a reputable pharmaceutical company that values precision and excellence.

Key Responsibilities

• Review and approve batch records, specifications, and other quality-related documentation.
• Participate in internal and external audits, ensuring readiness for regulatory inspections.
• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Develop and maintain Standard Operating Procedures (SOPs) and work instructions.
• Conduct risk assessments to identify potential quality issues and implement mitigation strategies.
• Monitor key quality performance indicators (KPIs) and report on trends to management.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• At least 3 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• In-depth knowledge of GMP (Good Manufacturing Practices) and regulatory guidelines (e.g., FDA, EMA).
• Experience with quality management systems (QMS) and audit procedures.
• Strong analytical skills and attention to detail.
• Effective written and verbal communication abilities.

Benefits

• Competitive annual salary with performance-based incentives.
• Comprehensive health, dental, and vision insurance coverage.
• Company pension scheme and life assurance.
• Generous paid time off and holiday entitlement.
• Professional development opportunities and training programs.