Internal Audit

- To carry out the internal audit of different GMP areas at site and inform to user department section HOD for justification/QMS.

- To follow the internal audit schedule and perform the audit as per SOP.

- To ensure compliance of training, validation and quality function pertaining to adherence with documents, system and procedure in accordance with the current regulatory expectation.

- Ensure for procedural compliance across the plant.

QMS Compliance

- Collect, evaluate data and identify the area of improvement, recommend and monitor effectiveness of CAPA.

- Ensure compliance of trend data of water system, environment monitoring system, change control, deviation, Incident, out of specification, CAPA, etc.

- To check the investigation of deviation and other non-compliances

Review of BMR & other GMP related documents

- To review of BMR & other GMP related documents and ensure compliance.

- To review Logs, its execution and compliance.

- To ensure the compliance of documents issuance ,distribution, retrieval and archival as per procedure

Engineering Compliance

- Review of calibration schedule of Equipments/instruments/ devices, its execution and compliance.





- Review of Preventive maintenance and calibration schedule & its execution of Equipments/instruments.

- To ensure well keeping of building maintenance as per respective checklist.

- To review Engg. Logs, SOPs, Layouts, its execution and compliance.

- Review and report verification of workplace monitoring system (EMS/BMS) and compliance.

Validation/qualification documents Compliance

- Review of validation/qualification documents in view of compliance.

- To verify Re qualification schedule for timely qualification completion.

- To verify whether qualification are performed as per defined SOP.

Regulatory Compliance

- To identify gaps between regulatory/compendia requirement and current practice/procedures
- To provide support to site during regulatory audit.

- To ensure compliance of training, validation and quality function pertaining to adherence with documents, system and procedure in accordance with the current regulatory expectation.

- To ensure cGMP and GLP compliance in quality control department.

- To ensure the compliance of retention sample and stability program as per the procedure.

Additional responsibilities assigned by head of the department.

📌 Executive - CQA Compliance - Thol (Ahmedabad)
🏢 Troikaa Pharmaceuticals
📍 Ahmedabad