Quality Assurance Manager

• Designation - Manager
• Exp - 10-15 years
• Location - Hyderabad Research Center

• Industry experience - CRO & CDMO Only.

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.