BDR
Great Place To Work Certified 2023
Pharmaceuticals Int'l Pvt. Ltd.
WE ARE HIRING
IPQA Manager
Department: Quality Assurance
Location: Baska, Vadodra
Responsible for monitoring, verification and review of all IPQA activities i.e. Manufacturing, Warehouse, Packing area and respective Standard Operating Procedures.
Part of cross functional team (CFT) for major investigations of issues impacting sterility
assurance like aseptic simulation failure, adverse environment monitoring trends, manufacturing level investigation for product sterility failures as well as on need basis for sterilization process validation failures.
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To ensure that Production adheres to GMP standards, procedures and systems in all respects of manufacturing including storage.
To ensure planning and coordination of IPQA related activity in coordination with supervisor to monitor Line clearance, IPM, Document review, sampling and SFG release activity.
To ensure and coordinate that all IPQA activities are being done as per SOP in line with cGMP.
To support in execution of the validation protocol, review and approval of process validation protocol/report and continued process verification protocol/report.
To support in drafting, review and approval of product APQR.
To support in execution of the media fill simulation study, review and approval of media fill simulation study protocol/report.
To review and approval of GMP documents like QRA, investigations reports, Qualification reports etc. Review and approval of qualification and requalification documents. Ensure the compliance of
quality risk assessment related to the manufacturing, packaging and equipment.
Responsible for Review and Approve of Master BMR/BPR and other Shop Floor document.
Responsible for review and approve the executed BMR/BPR and Batch release.
To involves in quality system i.e. change control process, deviation, risk assessment, and investigation related to equipment and utilities.
Support in drafting, review and approval SOP (QA, Production and Warehouse other departments) and its management in line with requirements of regulatory.
To involve in the investigation of the Deviation, Market complaint, Product recall and OOS/OOT related to shop floor
To support for implementation of corrective actions and preventive actions identified.
To participate in external inspections during shop floor area visit.
To participate as auditor for internal audit program and vendor qualification.
To approve all GMP documents on absence of QA Head.
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Participate in intra and inter departmental meeting & discussions.
Co-ordination with other departments for day-to-day activities.
To perform all the tasks assigned by the senior or reporting authority.
Submit your resume: aparna.das@bdrpharma.com