Sr. No.
Responsibilities

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Internal Audit

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

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

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

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Ensure for procedural compliance across the plant.

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QMS Compliance

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

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

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To check the investigation of deviation and other non-compliances

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Review of BMR & other GMP related documents

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

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To review Logs, its execution and compliance.

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To ensure the compliance of documents issuance ,distribution,



retrieval and archival as per procedure

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Engineering Compliance

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

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

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

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

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

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Validation/qualification documents Compliance

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Review of validation/qualification documents in view of compliance.

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To verify Re qualification schedule for timely qualification completion.

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To verify whether qualification are performed as per defined SOP.

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Regulatory Compliance

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

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To pr

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