Assistant Manager Quality Assurance required with 2-3 Year of similar experience in Pharma API/Intermediate/Chemical Industry.
Bsc, Msc Chemistry, BSc , Msc Microbiology, BPharm or Mpharm.
Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP. Responsible to perform the in-process test at different stages as per batch document/SOP.
Through knowledge of Issuance and control of documents BMR/ECR/BPR /Log books/SOPs/Label issuance and reconciliation.
Hands on Experience of VQ / Change control /Deviation/ Market complaint /DMF Readiness/Daily GMP formats / Process Validation Team work/
Having hands on knowledge of Audit readiness.
Performing the Gap analysis to find out the gaps in existing system. Preparing a compliance plan for closure of gaps. Execution of compliance plans Review of completion for compliance activity
Ensure validated status of all equipment's, manufacturing processes, and cleaning processes.
Review of protocols for qualification and validation of facility/ equipment / product / process.
Review of validation reports after execution of validation of facility /equipment / product / process.
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