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Qa Manager Qa Head For Api Manufacturing Company@solapur Jobs

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Job Description
Ensuring compliance to the established system to release or reject materials, intermediates and packing material.
ƒReleasing or rejecting all Active Pharmaceutical Ingredients and
Intermediates for use outside the control of the manufacturing
ƒEvaluation and Approval of Master batch Record and standard
operating procedure.
ƒReviewing and approving the change controls, if any major
changes done to the process taking prior approval from regulatory
agencies and customers.
ƒReviewing and investigating deviations and closed with time
bound CAPA.
ƒInvestigating product failure ( Out of specification, out of trend ,
extraneous peak ) with effective root cause analysis and CAPA.
ƒReviewing and investigating market complaints, returned goods
and closing of subsequent CAPA€™s.
ƒTraining : Conducting training programmes to all employees on
cGMP, SOP€™S , validation Activities and ensuring trainings
conducted as per approved schedule.
ƒDistribution, archival and control of the documents.
ƒMaking sure retain sample management and periodic inspection
as per procedure.
ƒEnsuring the internal audits / self-inspections is performed.
ƒReviewing and approval of process validation, cleaning validation
and equipment qualification protocols and reports.
ƒPlanning and coordination for validations like prospective ,concurrent and retrospective process validation, cleaning, drying , micronisation, blending validation, water validation. Performing validation and revalidation as per schedule.
ƒReviewing and approving Annual Product Quality Review reports .
ƒMaking sure for the initiation of holding time study for
intermediate stages.
ƒStability initiation for API and evaluation for shelf life.
ƒCompliance to the IPQA (In-process quality assurance), sampling activity.
ƒMaking sure all BMRs & Analytical data are reviewed prior to
release/dispatch of batch.
ƒInvolvement in Vendor Qualification activities such as review &
maintenance of the vendor related documents & approval or
rejection of vendors.
ƒShop floor rounds for online documentation and cGMP compliance.
ƒPreparation for Vendor Audits and Authority Audits (USFDA, WHO ,MHRA , KFDA and TGA) and compliance for audit report the non
conformances observed during audit.
Qualities Needed for This Jobs
Candidate Profile
Location:solapur €“ Maharashtra Post:quality Assurance- Manager Experience:13 To 17 Years In Api Salary: 09 Lakh To 12 Lakh P.a Additional:bus, Canteen
Looking for graduates profile.
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More Information
Location Solapur
Experience 13 (yrs)
Industry Computers / IT
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