Production OSD - Executive

USV PRIVATE LIMITED; Daman; On-site; INR 700,000 - 1,100,000; Full time

Job summary

USV PRIVATE LIMITED is seeking an executive in Production OSD to lead line operations across Granulation, Compression, Capsule Filling and Coating. The role requires proactive supervision, deviation handling, RCA, and CAPA implementation to ensure cGMP compliance and data integrity.

You will review CMRs, manage line clearances, and oversee IPQC checks to safeguard CQAs. You will also participate in PV activities, equipment qualification, and shift planning while upholding safety standards and

Qualifications

• Experience in large-scale pharmaceutical manufacturing operations.
• Proven ability to monitor multiple process steps and meet production targets.
• Strong understanding of deviations, CAPA, and change controls.

Responsibilities

• Direct and monitor Granulation, Compression, Capsule Filling, and Coating lines.
• Draft shop-floor deviations, perform RCA, and implement CAPAs.
• Review Batch Manufacturing Records for cGMP and data integrity.
• Oversee line clearance and cleaning during product changeovers.
• Conduct IPQC checks to ensure CQAs are met (weight, hardness, DT).
• Calculate batch yields, reconcile materials, analyze variances.
• Support PV, cleaning validation, IQ/OQ/PQ activities.
• Plan shifts, supervise operators and contract workers.
• Maintain audit readiness and enforce EHS and PPE protocols.

Skills

Line Operations Management

QMS Compliance

Root Cause Analysis

CAPA & Change Controls

cGMP & ALCOA+

IPQC & CQAs

Yield Tracking & Reconciliation

PV & Qualification Protocols (IQ/OQ/PQ

Shift Planning & Supervision

Audit Readiness & EHS

Job description

• 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.