Production OSD - Sr. Officer

PeopleStrong; Daman; On-site; INR 350,000 - 550,000; Full time

Job summary

PeopleStrong is seeking a diligent Shop-Floor Operations Specialist for our pharmaceutical manufacturing site in India. You will supervise granulation, compression, capsule filling, and coating, ensure equipment handling per validated parameters, and maintain ALCOA+ compliant BMR/BPR documentation.

You will lead IPQC testing, line clearance, and post-changeover safety/gowning, contributing to quality systems audits and CAPA when needed. Strong attention to detail and teamwork are essential.

Qualifications

• Supervise daily manufacturing operations across Granulation, Compression, Capsule filling, and Coating stages.

Responsibilities

• Operate and monitor core OSD machinery following validated parameters.
• Fill out and maintain BMR, BPR, and equipment logbooks per ALCOA+ data integrity.
• Perform cleaning and line clearance checks to prevent cross-contamination.
• Conduct IPQC tests (weight variation, thickness, hardness, friability, disintegration).
• Report shop-floor incidents and assist CAPA investigations.

Skills

Shop-floor operations

IPQC

GMP compliance

Line clearance

Safety & cleanroom

Equipment guidance

Tools

RMG

FBD

Rotary Tablet Presses

Auto-Coaters

Job description

Shop-Floor Operations:

Execute and supervise daily manufacturing operations across Granulation, Compression, Capsule filling, and Coating stages to hit target quantities.

Equipment Handling:

Operate and monitor core OSD machinery (e.g., RMG, FBD, Rotary Tablet Presses, Auto-Coaters) following validated process parameters.

BMR/BPR Documentation:

Fill out and maintain real-time entries in Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and equipment logbooks adhering strictly to ALCOA+ data integrity principles.

Line Clearance:

Perform and verify thorough cleaning (Type A/B) and line clearance checks at equipment and area changeovers to prevent cross-contamination or mix-ups.

In-Process Quality Control (IPQC):

Conduct routine IPQC tests (weight variation, thickness, hardness, friability, disintegration time, DT/leak tests) and record data promptly.

QMS Participation:

Report shop-floor incidents or process deviations immediately to senior management and assist in initial investigation logging and CAPA implementation.

Yield & Material Reconciliation:

Calculate stage-wise product yields, verify raw/packaging material quantities, and manage dispensing/reconciliation records accurately.

Operator Guidance:

Direct and guide machine operators and shop-floor helpers on daily operational tasks, cleanroom discipline, and machine safety.

Audit Compliance:

Keep work areas, processing rooms, and real-time records organized and ready for continuous internal and external regulatory audits (USFDA, MHRA, WHO).

Safety & Cleanroom Hygiene:

Enforce personal hygiene, proper cleanroom gowning practices, and strict adherence to plant EHS guidelines and PPE usage.