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Quality Assurance Manager
1 month ago
Key Responsibilities: GLP Compliance in Biology Function: Ensure that in vivo and in vitro biology studies conducted as part of Integrated Drug Discovery projects comply with OECD GLP, ISO 9001:2015, and ISO 17025:2017 guidelines.
Oversee quality systems and documentation associated with pharmacology, toxicology, DMPK, and other biology-related services.
SOP & Documentation Management: Prepare, review, and implement SOPs for biology labs in accordance with global regulatory requirements.
Maintain study plan copies, amendments, SOPs, QA records, training documents, and other facility-related documents.
Review of GLP Study Data: Review Study Plans/Amendments, Raw Data, and Study Reports for in vivo biology studies (e.g., efficacy, PK, safety) as conducted in IDD programs.
Verify data integrity and traceability of scientific results.
Training & Induction: Conduct GLP induction and periodic training for scientific and technical staff working in biology labs.
Ensure training SOP compliance and maintain training records.
Audit Trail & Scientific Software Review: Review and approve audit trails from software used in biology labs (e.g., data capture systems, LIMS, electronic lab notebooks).
Internal and In-Process Audits: Plan, conduct, and document audits of biology departments and related QA processes.
Identify gaps and drive CAPA implementation to close non-conformances.
Change Controls and CAPA Management: Manage quality events including Change Controls, Deviations, CAPAs, and Incidents across IDD biology functions.
Equipment Qualification and Calibration Review: Review IQ, OQ, PQ, and calibration records of biology lab instruments (e.g., animal study equipment, analytical tools).
Vendor & External Laboratory Audits: Qualify external testing labs and service providers related to biology studies and ensure their ongoing compliance through periodic audits.
Controlled Document Management: Handle issuance and retrieval of controlled forms, logbooks, and QA records for biology operations.
