Associate Director of Quality Control

2 weeks ago

London, Greater London, United Kingdom Proclinical Group Full time
Job Title: Associate Director, Client Management

Proclinical is seeking an experienced Associate Director to oversee Quality Control Stability. The successful candidate will lead a compliant stability program, including sample management, stability studies, and trending activities.

Key Responsibilities:

  1. Lead and manage the QC Stability team.
  2. Develop and implement a compliant stability program.
  3. Write and review SOPs, summary, and trend reports.
  4. Establish and maintain procedures for a compliant stability program.
  5. Manage stability chambers setup and equipment validation.
  6. Lead complex investigations into OOS or OOT results with cross-functional experts.
  7. Troubleshoot assays and implement solutions to drive continuous improvement.
  8. Oversee external vendors/contract testing facilities for QC Stability testing needs.
  9. Create and support execution of stability programs for products.
  10. Review and complete documentation in accordance with cGMP.
  11. Handle change control and deviations related to QC Stability.
  12. Author QC regulatory documentation and assist in regulatory audits/inspections.
  13. Develop and maintain a culture of continuous improvement within the QC team.
  14. Plan capacity for the QC Stability group to ensure resource availability.

Requirements:

  1. Degree in Chemistry, Biochemistry, Microbiology, or related science.
  2. Experience in GLP/GMP environments and laboratory-based testing.
  3. Management experience in a GMP-regulated environment.
  4. Strong analytical skills and technical experience in product/raw materials testing.
  5. Knowledge of statistical packages such as JMP.
  6. Proficiency in MS Word and Excel.
  7. Effective communication and organizational skills.
  8. Ability to work well as a team.

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