QC Analyst Raw Materials
LavipharmThe QC Analyst Raw Materials performs daily analytical testing of raw materials in compliance with cGMP and data integrity standards. Responsibilities include conducting compendial and in-house analyses, investigating out-of-specification results, preparing Certificates of Analysis, and maintaining laboratory equipment. Candidates must hold a BSc in Chemistry and possess over two years of quality control experience within the pharmaceutical industry.
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
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