Act as a representative of the QC department for Quality Control topics, with close collaboration with manufacturing during team meetings, Quality Councils, client meetings if applicable.
Apply scientific skills, knowledge and experience to provide advice and propose improvements where required.
Participates in the gap assessment, transfer, validation and implementation of new QC methods and equipment.
Write, review, and approval of quality documents (SOPs, stability protocols, reports, and quality instructions).
Draft and review method validation protocols and reports in line with regulatory guidelines. Participate in execution of method validation activities.
Generate, review and approve QC documents and acts as expert for QC during internal and external audits and inspections.
What we are looking for
Hands on experience (5+ years) in QC laboratory or related role within the pharmaceutical, biotechnology, or similar industry.
Extensive practical and technical knowledge of LC-MS and HPLC based methods and other laboratory techniques (e.g., ELISA, UV Spec)
Subject Matter Expert in QC assays; LC-MS, HPLC
Effective trainer and imparts regular trainings to QC team members
Extensive experience in Analytical Method Validation.
Interested? Send your CV to Daria at d.finikova@panda-int.com or call + 31202044502 for more info.