Quality Control Manager

Job Elements: -

• To effectively manage the activities of the Quality Control Section to ensure the achievement of compliance standards and meet business and customer expectations
• Ensure purchased materials and manufactured drug products are tested using registered methods and specifications which supports the effective management of the Supply Chain by efficient control of the Quality Control section.
• Approve specifications and test methodology for starting materials and finished drug products.
• Assess Quality Control methods, techniques and procedures and approve improvements or changes to comply with cGLP/cGMP requirements.
• Prepare and monitor the annual budget relating to Quality Control and recommend equipment and staff required to maintain efficient throughput of work.
• Approve contract services and additions/deletions to the authorised suppliers list.
• Recruit, train and discipline Quality Control staff in accordance with Company personnel policies. Maintain good employee relations, motivation and morale and safe working practices.
• Ensure technical agreements are in place with third parties to cover the testing of products.
• Ensure contract laboratories and service suppliers are regularly audited
• Support validation protocols for equipment, processes and laboratory analytical methods.
• Support Regulatory requests and compile registration information as appropriate.
• Support regulatory inspections by the MHRA and FDA.
• Review, trend and promote continuous improvement for laboratory key performance indicators such as out of specifications, batch failures, stability.
• Drive efficiencies and meet Quality and business key performance indicators
• Ensure an effective leadership and relationship with Quality Assurance
• Support the Global Quality requirements as necessary

The ideal candidate will have:

• A relevant scientific degree is essential and a higher degree is desirable
• Eligible for Qualified Person status under the provision of current EU legislation is preferable
• Experience at a senior level in Pharmaceutical Quality management and a thorough knowledge of GMP/FDA guidelines for the manufacture and testing of pharmaceutical products
• Analytically strong with highly developed knowledge and ability to specify and use IT systems to achieve process improvements and the conversion of data into meaningful business information
• Wide operating knowledge of analytical skills and an understanding of validation techniques.
• Excellent knowledge of Quality Management systems.
• Project management and project leadership experience, well developed planning skills with ability to meet deadlines
• Current driving licence is required