Review and approve physico-chemical QC analytical data packages (e.g., identity, purity, content, compendial tests) under cGMP, ensuring compliance with SOPs and Good Documentation Practices
Ensure timely tracking and closure of internal and external QC testing activities; escalate risks or delays proactively
Coordinate sample lifecycle activities (from pull to disposal) and manage associated documentation in collaboration with QC Project Lead and laboratory teams
Support investigations of deviations, OOX events, and CAPAs related to QC testing
Contribute to onsite customer or regulatory audits by providing QC-related documentation and clarifications
What we are looking for:
MSc or BSc in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
0–4 years of experience in QC or analytical development; prior exposure to GMP environments is advantageous
Basic understanding of physico-chemical analytical techniques (e.g., HPLC, CE/icIEF, protein content, pH, osmolality)
Familiarity with laboratory systems such as LIMS, Empower, or Electronic Lab Notebooks is a plus
Strong attention to detail, organizational skills, and ability to work within established procedures
Effective communication and collaboration skills; business fluent English (written and spoken)
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