DAMAN · FULLTIME
Production OSD - Executive
USV
Daman · onsite · Posted 9d ago
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Section · 01
About this role
- Job Description: Production OSD – Executive
- Line Operations Management: Direct and monitor daily unit operations across Granulation, Compression, Capsule Filling, and Coating sections to achieve production targets.
- QMS Compliance & Investigation: Initiate and draft shop-floor Deviations, perform Root Cause Analysis (RCA), and implement effective CAPAs and Change Controls.
- BMR/BPR Review: Review completed Batch Manufacturing and Packing Records in real time to ensure total adherence to cGMP and ALCOA+ data integrity standards.
- Line Clearance Execution: Supervise and verify strict line clearance and cleaning protocols (Type A/B) during product changeovers to eliminate cross-contamination risks.
- In-Process Quality Control: Enforce routine IPQC monitoring (tablet weight, hardness, friability, disintegration time, DT/leak tests) to maintain critical quality attributes (CQAs).
- Yield & Material Reconciliation: Calculate stage-wise batch yields, perform material reconciliation, and analyze variances to minimize process loss.
- Process Validation Support: Participate in the execution of continuous process validation (PV), cleaning validation, and equipment qualification protocols (IQ/OQ/PQ).
- Manpower & Shift Allocation: Allocate work schedules and supervise shift officers, machine operators, and contract workers to maximize machine utilization.
- Audit Readiness: Maintain cleanrooms, logbooks, and processing areas in a constant state of readiness for internal and external regulatory audits (USFDA, MHRA, WHO).
- EHS & Safety Enforcement: Enforce shop-floor safety guidelines, proper cleanroom gowning, correct personal hygiene, and mandatory usage of PPE.
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Section · 02
Skills
EHS Safety EnforcementQMS Compliance Investigationcleaning validationCGMPAudit Readinesschange controlsALCOALine Operations Management
Section · Company
About USV
USV
Pharma
7.1k+
employees
1961
65 years old
Mumbai, Maharashtra
India
About
USV India is the top old leading healthcare industry & pharmaceutical company in Mumbai, India. They provide API, Peptides, Biosimilars, Injectables, Ophthalmics & Solid Orals products in India
Industries
PharmaManufacturing
Employee ratings
1,753 reviews
4.0/ 5
Culture
3.8
Career growth
3.5
Work-life
3.8
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