Production OSD - Executive

PeopleStrong; Daman; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Pharma Compression Coatings Technology FBD Manufacturing seeks a Production OSD – Executive to oversee line operations, ensure QMS compliance, review batch records, and manage changeovers with strict adherence to cGMP and ALCOA+ standards.

The role requires postgraduate pharma qualifications and hands-on IPQC, yield reconciliation, and PV support to deliver quality products on schedule.

Qualifications

• Postgraduate degree in pharma or related field.
• M. Pharm or M.Sc. is required.
• Knowledge of cGMP and data integrity standards (ALCOA+).
• Experience in OSD manufacturing is advantageous.

Responsibilities

• 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 RCA, and implement CAPAs and Change Controls.
• BMR/BPR Review: Review Batch Manufacturing and Packing Records in real time for cGMP and ALCOA+ data integrity.
• Line Clearance Execution: Supervise line clearance and cleaning protocols during product changeovers to prevent cross-contamination.
• In-Process Quality Control: Enforce IPQC monitoring to maintain CQAs.
• Yield & Material Reconciliation: Calculate stage-wise batch yields, reconcile materials, and analyze variances to minimize losses.
• Process Validation Support: Participate in PV, cleaning validation, and IQ/OQ/PQ protocols.
• Manpower & Shift Allocation: Plan schedules and supervise staff to maximize machine utilization.
• Audit Readiness: Maintain cleanrooms, logbooks, and processing areas for regulatory audits.
• EHS & Safety Enforcement: Enforce safety guidelines and PPE usage on the shop floor.

Skills

Line operations

QA/QMS

Root Cause Analysis

CAPA & Change Controls

IPQC monitoring

Process validation

Material reconciliation

Audit readiness

EHS & safety

Education

M. Pharm

M.Sc.

Job description

Pharma Compression Coatings Technology FBD Manufacturing

Post Graduate

M. Pharm M.Sc.

CERTIFICATION

Working Language

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.