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 CoAs 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