Assistant Manager
Glenmark Pharmaceuticals · Not specified · onsite · Posted 51d ago
Undisclosed12–15 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Designation: Assistant Manager - Investigations (SIT)
Office Location: Chhatrapati Sambhajinagar
Primary Responsibilities: Review and evaluate Root Cause Analyses (RCA) associated with OOS (Out of Specification), OOT (Out of Trend), incidents, CAPAs, and Product Market Complaints for Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI), Nasal Sprays, Foams, and Oral Solid Dosage (OSD) formulations.
Provide scientific and technical evaluation of investigation findings to ensure robust root cause identification, effective CAPAs, and sustained product quality and compliance.
Review and develop a thorough understanding of product development reports, analytical method validation reports, and supporting scientific documentation.
Conduct detailed reviews of manufacturing operations for respiratory and oral solid dosage products, including process equipment, batch manufacturing records, Critical Process Parameters (CPPs), Critical Material Attributes (CMAs), and Critical Quality Attributes (CQAs).
Review and understand Quality Control laboratory operations involving analytical instruments such as HPLC, GC, UV-Visible Spectrophotometers, and other laboratory systems, including assessment of analytical raw data and laboratory investigations.
Ensure adherence to current regulatory requirements and quality compliance standards, while maintaining awareness of evolving global regulatory guidelines and industry best practices.
Apply statistical tools and data analysis techniques using Minitab software to support trend analysis, process capability assessments, investigation activities, and continuous improvement initiatives.
Required work experience
- Industry: Pharmaceutical
- Years of experience: 12-15 years
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Disclaimer: This job posting and Location 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
market complaintsAnalytical Method ValidationMinitabManufacturing OperationsHPLCBatch Manufacturinglaboratory operationsLaboratory SystemsOral Solid DosageManufacturingoperationsdata analysiscompliancePharmaceutical
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
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