Quality Control Manager (Maternity Cover)
Job Elements: -
• To manage and provide leadership to the Quality Control Analyst team to ensure that appropriate methods and strategies are developed in support of projects and routine commercial activities.
• Recruit, train and discipline Quality Control staff in accordance with Company personnel policies. Maintain good employee relations, motivation and morale and safe working practices.
• Support regulatory and customer inspections.
• Review, trend and promote continuous improvement for laboratory key performance indicators such as out of specifications, batch failures, stability.
• Ensure analysts are trained regarding the operation of equipment and performing of new methods and/or analytical techniques as well as company policies
• Responsible for assisting in investigation and root cause analysis of quality issues and laboratory based CAPAs.
• Keep up-to-date with the technical literature in field of expertise in order to identify appropriate analytical tests and methods
• Manage development and validation of methods for current projects, as well as ensuring all equipment is validated and maintained to the required standard.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements
• Complete chemical, physical or instrumental assays or tests on any pharmaceutical product, in-process material, or raw material for assigned products/projects when necessary.
• Approve specifications and test methodology for starting materials and finished products.
The ideal candidate will have:
• A relevant Chemistry based degree is essential
• Experience in laboratory management in the Pharmaceutical industry and experience of managing teams to tight deadlines. Experience of the food industry (in addition to the pharmaceutical industry) would be an advantage.
• Knowledge of Quality Management systems and GMP guidelines for the testing of pharmaceutical products.
• Wide operating knowledge of analytical skills and an understanding of validation techniques and requirements for pharmaceutical validation of analytical methods. Good experience with HPLC, GC and ICP essential.
• Able to develop and maintain strong working relationships with primary support functions.
• Excellent verbal/written communication and interpersonal skills
• Competent computer skills (Microsoft Office, Excel etc.)