Glp Compliance (Baddi)

Glp Compliance (Baddi)

22 Aug
|
Maya Biotech
|
Baddi

22 Aug

Maya Biotech

Baddi

To ensure compliance with Positive Laboratory Practice (GLP) requirements, applicable regulatory guidelines, company SOPs, protocols, and quality systems. The role is responsible for monitoring GLP studies, conducting inspections, reviewing documentation and data, identifying compliance gaps, and supporting continuous improvement of the laboratory quality system.

Key Responsibilities

1. GLP Compliance
- Ensure laboratory activities are performed in accordance with applicable GLP guidelines and internal procedures.
- Monitor compliance with approved study protocols, SOPs, specifications and regulatory requirements.
- Support implementation and maintenance of the GLP quality management system.
- Identify GLP compliance gaps and recommend appropriate corrective and preventive actions.

1. Quality Assurance Activities
- Conduct routine, study-based and facility/process inspections.
- Review study protocols, amendments, raw data, reports and supporting documentation.
- Verify that deviations, incidents and non-conformances are properly documented and investigated.




- Track CAPA implementation and effectiveness.
- Support internal and external regulatory inspections and audits.

1. Documentation & Data Integrity
- Review laboratory records for completeness, accuracy, traceability and compliance.
- Ensure compliance with ALCOA+ data integrity principles.
- Review controlled documents, SOPs, forms, logbooks and records.
- Ensure appropriate handling, correction, retention and archiving of GLP records.
- Support review of electronic data, audit trails and computerized systems where applicable

1. Study/Project Support
- Support Study Directors and laboratory personnel in GLP-compliant study execution.
- Verify that qualified personnel, equipment, facilities and procedures are available before and during studies.
- Review study-related documentation and identify discrepancies.
- Ensure appropriate documentation of protocol deviations and unexpected events.

1. Training
- Conduct

📌 Glp Compliance (Baddi)
🏢 Maya Biotech
📍 Baddi

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