About us
Bristol Laboratories Ltd is one of the leading and fastest growing pharmaceutical companies in the United Kingdom engaged in the development, manufacturing, marketing and distribution of generic medicines, as well as formulation brands. We have state-of-the art manufacturing facilities in Luton & Peterlee.
As a result of continued growth and expansion, we have an excellent opportunity to appoint Quality Control Team Leader in Peterlee.

About the job
Key Responsibilities:

• Manage stability testing programs and the quality of pharmaceutical products according to regulatory requirements.

• 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 comply with regulatory standards, including but not limited to GMP, GLP, MHRA and EMA guidelines.

• Execution of GEMBA Walks.

• Ensure providing stability summary data for PQR preparation on timely manner.

• Oversee the maintenance of accurate records and documentation related to stability studies and testing results.

• To ensure operation/maintenance and management of stability chambers including mapping, calibration, periodic maintenance and good housekeeping.

• Maintain and calibrate testing instruments and equipment, ensuring they are in proper working condition.

• Analyse 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.

• To review the analytical documents and other data/reports and periodic review of the documentation as required.

• To 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 related science preferred but not essential.
• Relevant analytical experience in the pharmaceutical industry in QC & ADL.
• Thorough understanding of cGMP guidelines.
• 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 to drive forward and deliver operating plan objectives.
• Good organizational and strategic planning skills