QC Supervisor Finished Products

Lavipharm is seeking a Supervisor of FP, based in Athens, who will be responsible for supervising the day-to-day testing and release-support activities of the FP QC team, ensuring analyses are performed accurately, on time, and in full compliance with cGMP, Good Documentation Practices (GDP) and data integrity requirements.

Requirements

Supervises and coordinates the daily activities of the Semi-Finished, FP Release and Stability Programs, Process, Analytical and Cleaning Validation analysis ensuring workload is prioritized to meet business objectives and defined timelines Trains, develops and performs performance reviews of QC FP team members, ensuring they are equipped with the skills and knowledge to perform their roles effectively Collaborates with QA, production, supply chain, RA, RnD and engineering teams to resolve quality-related issues and enhance product quality Leads team Problem solving and troubleshooting sessions towards continuous improvement of QC Operations in FP Monitors compliance of the FP team to all procedures, specifications, GMP and safety rules of the QC Laboratory Champions Good Documentation Practices (GDP) and data integrity (ALCOA+) principles across the FP QC team, ensuring records are accurate, legible, contemporaneous, original and attributable Leads as required and approves the investigation of OOS/OOT results Reviews & Approves Co.

As Hosts and supports internal and external audits and regulatory inspections related to FP QC, ensuring timely and accurate responses Owns and progresses deviations and change controls related to FP testing through to closure Ensures instruments and computerized systems used for FP testing are properly qualified, maintained, calibrated and in proper operation, in accordance with applicable procedures Requirements BSc in Chemistry, Postgraduate degree in Pharmaceutical Science or related field is a plus At least 10 years' experience in the Pharma industry within Quality Control operations, including exposure to FP testing At Least 3 years in supervisory roles in QC Operations Advanced Knowledge of the English language Computer Literacy (MS Office, ERP System) eQMS/eDMS experience will be considered a plus