CIPLA Career Opportunities: Junior 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
2 years of experience in quality assurance department
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