QC Analyst Raw Materials

Lavipharm is seeking a QC Analyst Raw Materials, based in Athens, who will be responsible for performing the day-to-day analytical testing of raw materials, including identification, assay and compendial/in-house testing, ensuring results are accurate, timely, and generated in full compliance with cGMP, Good Documentation Practices (GDP) and data integrity requirements.

Responsibilities

Carries out testing assignments (raw material identification, assay and compendial/in-house analysis) and prioritizes daily workload as directed by the QC Supervisor (RM&PM) , escalating any issue affecting timelines Performs testing of raw materials according to both in-house registered methods and compendial (pharmacopoeial) methods, as applicable Follows all procedures, specifications, GMP and safety rules of the QC Laboratory Adheres to Good Documentation Practices (GDP) and data integrity (ALCOA+) principles, ensuring records are accurate, legible, contemporaneous, original and attributable Conducts investigation of OOS/OOT results, under the guidance of the QC Supervisor (RM&PM) Drafts and updates SOPs, test methods, sampling and work instructions as applicable, for Supervisor review Prepares Co.

As of raw materials Uses and maintains instruments and computerized systems relevant to RM testing, ensuring qualification, maintenance and calibration status is current Supports method verification/validation and analytical method transfer activities for RM test methods Requirements BSc in Chemistry, Postgraduate degree in Pharmaceutical Science or related field is a plus More than 2 years' experience in the Pharma industry within Quality Control operations, including exposure to RM testing Very good knowledge of the English language Computer Literacy (MS Office, ERP System) eQMS/eDMS experience will be considered a plus