Job Description

Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines

Accountabilities

I. Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner

II. Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies

III. Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness

IV. Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement

V. Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of current products smoothly

VI.



Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals

VII. Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements

VIII. Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning

IX. Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP

X. Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements

XI. Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction

📌 Junior Team Member Qa Thane
🏢 Cipla
📍 Thane