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Manager QA
2 weeks ago
Having 1520 years of experience inpharmaceutical industry and acting as site
QA Head rolesince last 5 years (Oral solid dosage form/Injectable dosageform).
To ensure overall compliance ofcGMP/GLP Practices at plant:
Ensure that all the inprocess QA activities carried out as per therequirement
and resolve day to day operational relatedissues.
Harmonization of Quality Managementsystem.
Establishing effective Quality systems standards& cGMP procedure at site.
Authorize all masterdocuments viz. SOP Master Production/Packing Control
Records
Validation/Qualification Protocols and ReportsStandard Testing Procedure
Annual Productreview.
Review Reports Analytical Method TransferReports etc. and relevant formats.
Effective adherenceto the training system to ensure cGMP activities are
performed by trained and qualified persons.
TrainingSelfInspection etc. and monitoring of the adherence of theschedule.
Ensure successful regulatory inspection andtimely closure of regulatory
commitments.
Ensure good documentation practices followed to paper andelectronic records
Ensure adherence of Data IntegrityPolicy.
Hands on experience on review and approval ofQMS elements viz. Change
Controls
Ensureadherence of Data Integrity Policy. Handson experience on review and approval of QMS elements viz.
Change
Controls Deviation Investigation CAPA. Marketcomplaint and Product Recall
Ensure effective corrective/ preventive actions are implemented.
Effectively andtimely closure of market complaints OOS OOT and otherQMS
elements.
Ensure to provide technicalsupport and timely submission of documents to
regulatory. To ensure electronic software implementation
Responsible for Batch Release
Review and approval oftechnical agreements.
Hands on exposure on 21 CFR part11 / EU
cGMP requirements for process equipmentqualification / Lab instrument.
Ensure compliance ofprocess validation cleaning validation and equipment /
utility qualification including media fill and smoke study. Ensurethat the
processes and system remains in a state ofvalidation and compliance. QA
oversight in QCactivities
Hands on experience on various regulatoryaudits i.e. USFDA MHRA / EMA
ANVISATGA
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