Executive - CQA Compliance - Thol

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 environment 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.