Production - Senior Executive

PeopleStrong; Daman; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

PeopleStrong seeks a hands-on Shop Floor Production & QA lead to oversee Granulation, Compression, Coating and Capsule filling, ensuring targets are achieved safely and on schedule.

You will own QMS investigations, CAPA, and batch record reviews with ALCOA+ data integrity, while coordinating PV/IQ/OQ/PQ activities with Tech Transfer and leading yield optimization initiatives across the line.

Qualifications

• Experience on shop floor with granulation, compression, coating, and capsule filling.
• Ability to lead QMS investigations including RCA, CAPA, deviation reports.
• Familiarity with ALCOA+ data integrity and BMR/BPR review processes.
• Knowledge of IPQC, CPPs, and CQAs in pharmaceutical manufacturing.
• Experience with Process Validation batches and equipment IQ/OQ/PQ.

Responsibilities

• Lead shift operations across Granulation, Compression, Coating, and Capsule filling to meet targets safely and on schedule.
• Own and drive QMS tasks, including drafting deviation reports, RCA, CAPA, and Change Control actions.
• Review Batch Manufacturing Records and Batch Packing Records for ALCOA+ data integrity before QA submission.
• Authorize and verify line clearances, washings, and handovers during batch/product changeovers.
• Monitor CPPs/CQAs during processing to ensure IPQC compliance and spec adherence.
• Lead floor PV activities, swabbing/sampling, and coordinate IQ/OQ/PQ with Tech Transfer.
• Analyze stage yields, perform material reconciliations, and drive yield improvement initiatives.
• Manage floor staff and shifts; optimize OEE and resource allocation to reduce bottlenecks.
• Represent the site as SME during internal audits and regulatory inspections (USFDA, MHRA, WHO, EMA).
• Enforce EHS policies and conduct cGMP training for shop-floor personnel.

Skills

Shop-floor leadership

QMS CAPA

Batch Records

ALCOA+ data

IPQC CQAs

PV Validation

Yield optimization

OEE

Audit readiness

GMP compliance

Job description

• Shop-Floor Execution & Supervision: Lead shift operations across Granulation, Compression, Coating, and Capsule filling to ensure production targets are achieved safely and on schedule.
• QMS Investigation Lead: Own and drive shop-floor Quality Management System tasks, including drafting detailed Deviation reports, conducting Root Cause Analysis (RCA), and executing CAPA and Change Control actions.
• Batch Record Review & Audit Readiness: Perform comprehensive technical reviews of executed Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) to ensure strict ALCOA+ data integrity prior to QA submission.
• Line Clearance & Cross-Contamination Prevention: Authorize and verify critical Type A/B line clearances, equipment washings, and room handovers during batch or product changeovers.
• In-Process Quality Oversight: Monitor critical process parameters (CPPs) and critical quality attributes (CQAs) during processing, ensuring full compliance with IPQC standards and weight/hardness/disintegration limits.
• Validation & Scale-Up Support: Lead the floor execution of Process Validation (PV) batches, cleaning validation swabbing/sampling, and equipment qualifications (IQ/OQ/PQ) in coordination with Tech Transfer.
• Yield Optimization & Material Reconciliation: Analyze stage-wise batch yields, execute material reconciliations, investigate raw material losses, and implement yield improvement initiatives.
• Resource & Shift Scheduling: Manage floor operators, technicians, and shift staff; allocate machinery effectively to eliminate bottlenecks and optimize overall equipment effectiveness (OEE).
• Audit SME Representation: Act as a front-line Subject Matter Expert (SME) during internal audits and regulatory inspections (USFDA, MHRA, WHO, EMA), presenting batch execution records and shop-floor controls.
• EHS & Training Compliance: Enforce strict adherence to plant Environmental Health & Safety (EHS) policies, cleanroom gowning standards, and conduct routine technical cGMP training for shop-floor personnel.