CIPLA Career Opportunities: Team Member – QA B. Pharma/ M.Sc Apply Now
Job Purpose
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 new 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
Education Qualification
B. Pharma/ M.Sc
Relevant Work Experience
3-4 years of experience in quality assurance department
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