Quality Assurance Manager

4 weeks ago

Hyderabad, Telangana, India PI Health Sciences Ltd Full time
  • 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.

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