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Quality Assurance Team Lead

2 months ago

Langleydale County Durham, United Kingdom Bristol Laboratories Ltd Full time
Job Description:

Bristol Laboratories Ltd is a leading pharmaceutical company engaged in the development, manufacturing, marketing, and distribution of generic medicines and formulation brands. We are seeking a highly skilled Quality Control Team Leader to join our team in Peterlee.

Key Responsibilities:
  • Manage Stability Testing Programs: Ensure the quality of pharmaceutical products meets regulatory requirements.
  • Supervise Quality Control Analysts: Provide guidance, training, and support to ensure accurate and timely testing and reporting.
  • Ensure Regulatory Compliance: Ensure all stability testing activities comply with GMP, GLP, MHRA, and EMA guidelines.
  • Provide Stability Summary Data: Ensure timely provision of stability summary data for PQR preparation.
  • Maintain Accurate Records: Oversee the maintenance of accurate records and documentation related to stability studies and testing results.
  • Operate and Maintain Stability Chambers: Ensure the operation, maintenance, and management of stability chambers, including mapping, calibration, periodic maintenance, and good housekeeping.
  • Maintain Testing Instruments: Maintain and calibrate testing instruments and equipment to ensure they are in proper working condition.
  • Analyze Stability Data: Analyze and interpret stability data, identifying trends and potential deviations, and report findings to the Quality Control Manager.
  • Collaborate with Cross-Functional Teams: Collaborate with Research and Development, Regulatory Affairs, and Production teams to address quality and stability concerns.
  • Assist in Audits: Assist in internal and external audits by providing documentation and data related to stability testing activities.
  • Review Analytical Documents: Review analytical documents and other data/reports and periodic review of the documentation as required.
  • Provide Training: Provide training in the department regarding SOPs, GLP, GMP, GTP, and health and safety.
  • Ensure Effective Communication: Ensure timely and effective communication and escalation process to raise quality issues to the appropriate levels of management.
Requirements:
  • Relevant Analytical Experience: Relevant analytical experience in the pharmaceutical industry in QC & ADL.
  • Dynamic Work Environment: Ability to excel in a dynamic, fast-paced work environment.
  • Computer Skills: Competent computer skills (Microsoft Office, Excel, etc.).
  • Organizational Skills: Good organizational and strategic planning skills.