QC Supervisor Finished Products

About this role

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 CoAs
• 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