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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