Production - Assistant Manager

PeopleStrong; Daman; Vor Ort; INR 4.000.000 - 7.000.000; Vollzeit

Zusammenfassung

PeopleStrong is seeking a Production Operations Leader to supervise daily manufacturing across Granulation, Compression, Coating and Capsule filling, ensuring targets are met and line efficiency is maximized.

You will drive QMS compliance, lead investigations (Deviations, CAPAs, Change Controls, OOS/OOT), perform final technical reviews on batch records for ALCOA+ data integrity, and support regulatory inspections (USFDA, MHRA, EMA, WHO).

Qualifikationen

• Lead daily manufacturing schedules across Granulation, Compression, Coating, and Capsule filling to meet targets and boost line efficiency.
• Drive shop-floor QMS compliance by initiating, investigating, and closing Deviations, CAPAs, Change Controls, and OOS/OOT using RCA methods.
• Perform final technical reviews of Batch Manufacturing and Packing Records to ensure ALCOA+ data integrity before QA batch release.
• Act as SME during regulatory inspections (USFDA, MHRA, EMA, WHO), presenting shop-floor practices and process controls.
• Coordinate and supervise PV, cleaning validation, and equipment qualification (IQ/OQ/PQ) for scale-up and new products.
• Analyze stage-wise batch yields, perform material reconciliations, and drive Lean/5S to minimize losses and expand capacity.
• Work with PPC, QA, QC, Engineering, and Tech Transfer to ensure raw material availability and minimize downtime.
• Oversee high-speed OSD equipment (RMG, FBD, auto-coaters, rotary presses) and evaluate automation upgrades.
• Manage shift officers and operators; evaluate performance, design training matrices, and foster compliance and continuous learning.
• Enforce strict EHS policies, cleanroom zoning, gowning protocols, and workplace safety guidelines.

Aufgaben

• Lead and oversee daily manufacturing schedules across Granulation, Compression, Coating, and Capsule filling sections to meet production targets and optimize line efficiency.
• Drive shop-floor Quality Management System compliance by initiating, investigating, and closing Deviations, CAPAs, Change Controls, and OOS/OOT occurrences using RCA methodologies (e.g., Fishbone, 5-Why).
• Perform final, high-level technical reviews of completed Batch Manufacturing and Packing Records to guarantee total compliance with ALCOA+ data integrity principles prior to QA batch release.
• Act as a technical Subject Matter Expert (SME) during internal and external regulatory inspections (USFDA, MHRA, EMA, WHO), presenting shop-floor practices, logbooks, and process controls.
• Coordinate and supervise the execution of continuous Process Validation (PV), cleaning validation, and equipment qualification protocols (IQ/OQ/PQ) for scale-up and new product launches.
• Analyze stage-wise batch yields, perform complex material reconciliations, and drive Lean/5S initiatives to minimize process losses, reduce cycle times, and expand capacity.
• Work closely with Production Planning and Control (PPC), Quality Assurance (QA), Quality Control (QC), Engineering, and Tech Transfer to ensure seamless raw material availability and minimize equipment downtime.
• Oversee the operational performance of high-speed OSD equipment (e.g., RMG, FBD, auto-coaters, rotary tablet presses) and evaluate automation upgrades to boost productivity.
• Manage shift officers, executives, and operators; evaluate team performance, design training matrices, and foster a strong culture of compliance and continuous learning.
• Enforce strict adherence to plant Environmental Health & Safety (EHS) policies, cleanroom zoning, structural gowning protocols, and workplace safety guidelines.

Jobbeschreibung

Production Operations Leadership:

Lead and oversee daily manufacturing schedules across Granulation, Compression, Coating, and Capsule filling sections to consistently meet production targets and optimize line efficiency.

QMS Management & Investigations:

Drive shop-floor Quality Management System compliance by initiating, investigating, and closing Deviations, CAPAs, Change Controls, and OOS/OOT occurrences using RCA methodologies (e.g., Fishbone, 5-Why).

BMR/BPR Final Technical Review:

Perform final, high-level technical reviews of completed Batch Manufacturing and Packing Records to guarantee total compliance with ALCOA+ data integrity principles prior to QA batch release.

Audit Representation & SME:

Act as a technical Subject Matter Expert (SME) during internal and external regulatory inspections (USFDA, MHRA, EMA, WHO), presenting shop-floor practices, logbooks, and process controls.

Process & Cleaning Validation:

Coordinate and supervise the execution of continuous Process Validation (PV), cleaning validation, and equipment qualification protocols (IQ/OQ/PQ) for scale-up and new product launches.

Yield Improvement & Capacity Planning:

Analyze stage-wise batch yields, perform complex material reconciliations, and drive Lean/5S initiatives to minimize process losses, reduce cycle times, and expand capacity.

Cross-Functional Alignment:

Work closely with Production Planning and Control (PPC), Quality Assurance (QA), Quality Control (QC), Engineering, and Tech Transfer to ensure seamless raw material availability and minimize equipment downtime.

Equipment & Automation Optimization:

Oversee the operational performance of high-speed OSD equipment (e.g., RMG, FBD, auto-coaters, rotary tablet presses) and evaluate automation upgrades to boost productivity.

Team Supervision & Skill Development:

Manage shift officers, executives, and operators; evaluate team performance, design training matrices, and foster a strong culture of compliance and continuous learning.

EHS & Cleanroom Compliance:

Enforce strict adherence to plant Environmental Health & Safety (EHS) policies, cleanroom zoning, structural gowning protocols, and workplace safety guidelines.