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Senior Quality Assurance Specialist
2 weeks ago
Job Title: Senior Quality Assurance Specialist
Job SummaryWe are seeking a highly experienced Quality Assurance Manager to oversee quality systems and documentation associated with pharmacology, toxicology, DMPK, and other biology-related services.
Main Responsibilities:- Ensure compliance with GLP, ISO 9001:2015, and ISO 17025:2017 guidelines in the biology function.
- Oversee quality systems and documentation for pharmacology, toxicology, DMPK, and other biology-related services.
- Develop, review, and implement Standard Operating Procedures (SOPs) for biology labs according to global regulatory requirements.
- Maintain study plan copies, amendments, SOPs, QA records, training documents, and other facility-related documents.
- Review Study Plans/Amendments, Raw Data, and Study Reports for in vivo biology studies as conducted in IDD programs.
- Verify data integrity and traceability of scientific results.
- Conduct GLP induction and periodic training for scientific and technical staff working in biology labs.
- Ensure training SOP compliance and maintain training records.
- Review and approve audit trails from software used in biology labs.
- Plan, conduct, and document audits of biology departments and related QA processes.
- Identify gaps and drive implementation of Corrective Action Preventative Actions (CAPAs) to close non-conformances.
- Manage quality events including Change Controls, Deviations, CAPAs, and Incidents across IDD biology functions.
- Review IQ, OQ, PQ, and calibration records of biology lab instruments.
- Qualify external testing labs and service providers related to biology studies and ensure ongoing compliance through periodic audits.
- Handle issuance and retrieval of controlled forms, logbooks, and QA records for biology operations.
