Senior Officer
Glenmark Pharmaceuticals · Not specified · onsite · Posted 65d ago
Undisclosed6–8 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Conducted in-processquality checks and line clearance activities during manufacturing and packagingoperations to ensure cGMP compliance.
Performed sampling atvarious stages of manufacturing and packaging as per approved procedures andspecifications.
Managed electronic batchrecords (EBR) through ProcessXE and created/maintained formats in eBPCR.
Drafted, reviewed, andrevised SOPs and quality documents using the QEDGE document management system.
Compiled, analyzed, andtrended data for Annual Product Quality Reviews (APQRs) to support productquality assessment and continuous improvement.
Prepared ContinuedProcess Verification (CPV) reports, including statistical trending of criticalprocess parameters and quality attributes.
Executed and reviewedProcess Validation, Cleaning Validation, and Hold Time Studies in accordancewith approved protocols and regulatory requirements.
Reviewed and releasedbatch manufacturing and packaging records for domestic and export markets,ensuring compliance with GMP and market-specific requirements.
Coordinated withProduction, Quality Control, Quality Assurance, and Regulatory Affairs teamsfor investigation, documentation, and batch disposition activities.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Document Managementprocess validationcleaning validationCGMPExportProduct qualityRegulatory AffairsSamplingBatch Manufacturingline clearancecpvQuality AssuranceQuality ControlManufacturingoperationscompliance
About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals
Pharma
13.5k+
employees
1977
49 years old
Mumbai, Maharashtra
India
About
Glenmark Pharma is discovering advance therapies for a new world. Ceating centers of excellence in dermatology, oncology, etc
Industries
Pharma
Employee ratings
3,706 reviews
3.8/ 5
Culture
3.6
Career growth
3.2
Work-life
3.6
Employees rate it well for
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