Process Incharge - Production (QMS)
Otsuka Pharmaceutical · Ahmedabad · onsite · Posted 19d ago
Undisclosed3–7 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- Prepare, review and control critical production documents for parenteral manufacturing, including BMRs, SOPs, logbooks, protocols and other related manufacturing records.
- Ensure compliance of production activities with cGMP, GDP, approved SOPs and established manufacturing procedures.
- Monitor and review shop-floor documentation and manufacturing records for completeness, accuracy and compliance with approved procedures.
- Lead and coordinate production-related incident and deviation investigations, including root-cause analysis using tools such as 5-Why and Fishbone; and ensure timely closure.
- Initiate, track and implement CAPA and Change Control activities related to production processes, equipment and documentation.
- Support Quality Risk Management activities related to manufacturing processes and identify opportunities for process and compliance improvement.
- Review production logbooks, online records and relevant audit trails to ensure proper documentation and traceability.
- Support preparation, review and execution of validation-related activities, including media fill documentation and protocols.
- Coordinate implementation of revised SOPs and procedures and provide training to production personnel on applicable GMP and documentation requirements.
- Support internal, customer and regulatory audits by providing required production records, QMS documentation and necessary shop-floor support.
- Maintain effective coordination with QA, Engineering, QC and other cross-functional teams for timely closure of production-related QMS activities.
Sourced from naukri
Skills
SOPCGMPdeviationMedia FillCAPAChange ControlRoot Cause AnalysisParenteralInjectablesProduction QmsGDPQMSGMPPharmaceutical
About Otsuka Pharmaceutical India Private Limited
Otsuka Pharmaceutical
Pharma
950
employees
2016
10 years old
Ahmedabad, Gujarat
India
About
Japanese MNC with Indian Heart
Industries
PharmaManufacturing
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