Associate Director for Quality Control Stability

2 weeks ago


Oxford, Oxfordshire, United Kingdom Proclinical Staffing Full time
Job Overview

Proclinical is seeking an experienced Associate Director to oversee Quality Control Stability in a compliant program. The successful candidate will be responsible for setting up and overseeing a compliant stability program, leading stability studies, driving continuous improvement, and supporting compliant testing applications for marketing approval and commercial supply.

Key Responsibilities:

  • Manage the compliant stability program, including sample management, stability studies, and trending activities.
  • Lead and oversee the QC Stability team.
  • Write and review SOPs, summary, and trend reports.
  • Establish and maintain procedures for a compliant stability program.
  • Manage stability chambers setup and equipment validation.
  • Lead complex investigations into OOS or OOT results with cross-functional experts.
  • Troubleshoot assays and implement solutions to drive continuous improvement.
  • Oversee external vendors/contract testing facilities for QC Stability testing needs.
  • Create and support execution of stability programs for products.
  • Review and complete documentation in accordance with cGMP.
  • Handle change control and deviations related to QC Stability.
  • Author QC regulatory documentation and assist in regulatory audits/inspections.
  • Develop and maintain a culture of continuous improvement within the QC team.

Requirements:

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


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