Sr. No.

Responsibilities

1. Internal Audit

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

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

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

1. Ensure for procedural compliance across the plant.

2. QMS Compliance

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

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

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

3.

Review of BMR & other GMP related documents

3.

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

3.

To review Logs, its execution and compliance.

3.

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

4.

Engineering Compliance

4.

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

4.





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

4.

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

4.

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

4.

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

5.

Validation/qualification documents Compliance

5.

Review of validation/qualification documents in view of compliance.

5.

To verify Re qualification schedule for timely qualification completion.

5.

To verify whether qualification are performed as per defined SOP.

6.

Regulatory Compliance

6.

To identify gaps between regulatory/compendia requirement and current practice/procedures

6.

To provide support to site during regulatory audit.

7.

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

8.

To ensure cGMP and GLP compliance in quality control department.

9.

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

10.0

Additional responsibilities assigned by head of the department.

📌 CQA-compliance (Ahmedabad)
🏢 Troikaa Group
📍 Ahmedabad