Quality Assurance Manager

7 days ago


Shotton, United Kingdom Bristol Laboratories Ltd Full time

About Bristol Laboratories Ltd

Bristol Laboratories Ltd is a leading pharmaceutical company in the United Kingdom, specializing in the development, manufacturing, marketing, and distribution of generic medicines and formulation brands. Our state-of-the-art manufacturing facilities in Luton and Peterlee enable us to deliver high-quality products to the market.

About the Job

We are seeking a highly skilled and experienced Quality Control Team Leader to join our team in Peterlee. The successful candidate will be responsible for managing stability testing programs and ensuring the quality of pharmaceutical products according to regulatory requirements.

Key Responsibilities:

  • Manage stability testing programs and ensure compliance with regulatory standards, including GMP, GLP, MHRA, and EMA guidelines.
  • Supervise a team of Quality Control Analysts, providing guidance, training, and support to ensure accurate and timely testing and reporting.
  • Ensure all stability testing activities are conducted in accordance with established procedures and protocols.
  • Execute GEMBA Walks to monitor and improve quality control processes.
  • Provide stability summary data for PQR preparation in a timely manner.
  • Oversee the maintenance of accurate records and documentation related to stability studies and testing results.
  • Maintain and calibrate testing instruments and equipment to ensure they are in proper working condition.
  • Analyze and interpret stability data, identifying trends and potential deviations, and report findings to the Quality Control Manager.
  • Investigate OOS/OOT/LIR results and initiate appropriate Corrective and Preventive Action (CAPA).
  • Collaborate with cross-functional teams, including Research and Development, Regulatory Affairs, and Production, to address quality and stability concerns.
  • Assist in internal and external audits by providing documentation and data related to stability testing activities.
  • Review analytical documents and other data/reports and perform periodic reviews of documentation as required.
  • Undergo and provide training in the department regarding SOPs, GLP, GMP, GTP, and health and safety.
  • Ensure timely and effective communication and escalation process to raise quality issues to the appropriate levels of management.

Requirements:

  • Education in Pharmaceutics, Chemistry, or a related science is preferred but not essential.
  • Relevant analytical experience in the pharmaceutical industry in QC & ADL is required.
  • Thorough understanding of cGMP guidelines is essential.
  • Ability to excel in a dynamic, fast-paced work environment.
  • Excellent verbal/written communication and interpersonal skills.
  • Competent computer skills (Microsoft Office, Excel, etc.).
  • Ability to embrace change and drive forward and deliver operating plan objectives.
  • Good organizational and strategic planning skills.

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