QC Sample Management Team Supervisor

Overview

The role of the QC Sample Management Team Supervisor (18 month Fixed Term Contract) is to coordinate and support site with all sample management activities, from receipt and distribution to the relevant labs internally to the shipping of samples to 3rd party laboratories. Also responsible for the control of retains in compliance with ICH, WHO, the company quality guidelines and SOPs and other regulatory requirements.

• Provide direction to the team and ensure that mandatory training is in place.
• Encourage optimal performance of staff through training, feedback, coaching and development planning in conjunction with the manager.
• Track attendance and timekeeping and lead disciplinary/counselling sessions.
• Actively promote positive change.
• Ensure appropriate standards of cGMP, housekeeping, Health and Safety and Environment are applied in the team, in accordance with current regulations and procedures.
• Be permanently inspection ready.
• Ensure the maintenance and qualification of the specified equipment is kept up to date and at the required GMP standards.
• Ensure the use of only approved and validated test processes.
• Own and investigate deviations arising from sample management activities.
• Coordinate site sample management activities.
• Oversee the aseptic sampling requirement of manufacturing, stability and raw material samples.
• Coordinate the receipt and distribution of samples from secondary manufacture to the QC Labs.
• Coordinate with QA and supply chain departments the requirements of OMCL samples to support batch release.
• Track the receipt of third-party samples against the shipping schedule and escalate any delays in receipt of samples to the stability manager.
• Coordinate the sampling of third-party routine samples and distribution to the laboratories in a timely manner to prevent delays to batch release.
• Coordinating the receipt of stability samples, reserve samples and retain samples from third party suppliers and store/distribute following site procedures.
• Participate in improvement project teams (e.g., Lean labs) where required driving quality decisions and provide advice and technical support where required.
• Coordinate completion of and resulting activities.
• Manage the storage, annual inspection and disposal of the final product retain samples on behalf of the site Qualified Person(s).

Bachelor's degree in a relevant scientific discipline (Chemistry, Biology, Biochemistry, etc.).

• Proven quality control experience in the pharmaceutical/biotech/or other regulated industry.
• Leadership/ team management skills.
• Direct interaction with regulatory agencies.
• Knowledge of current Good Manufacturing Practices (cGMP) principles.
• Knowledge of FDA and EMA requirements.