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Assistant Production Manager – API Manufacturing

TIVAN SCIENCES PRIVATE LIMITED · Rajkot

New
🇬🇧 English
reactors centrifuges filters dryers (FBD, VTD, RCVD) distillation solvent recovery cGMP compliance GDP

Job description

About the role

The Assistant Production Manager will support the Production Head in running day‑to‑day API manufacturing operations. The role is responsible for production planning, shift leadership, cGMP compliance on the shop floor, and continuous improvement in yield, cycle time and cost.

Key responsibilities

  • Plan and execute monthly production schedules for multi‑product API blocks in line with sales and dispatch requirements.
  • Lead and allocate manpower across shifts, ensuring smooth handovers.
  • Execute batches according to approved BMR/BPR and SOPs, and close batch records on time.
  • Handle deviations, investigations, CAPA and change controls in coordination with QA.
  • Monitor yields, cycle times, solvent consumption and recovery, driving improvement projects.
  • Support scale‑up, process validation and technology transfer from R&D to plant.
  • Coordinate with QC, QA, Engineering, Stores and Planning for uninterrupted operations.
  • Prepare for and participate in WHO‑GMP, regulatory and customer audits.
  • Enforce EHS and process safety practices, including PPE and permit systems.
  • Train and develop production staff on SOPs, cGMP and safety.

Required profile

  • M.Sc / B.Sc Chemistry or B.E / B.Tech Chemical Engineering.
  • 5–8 years of experience in API / bulk drug manufacturing, with at least 2 years in a supervisory or shift‑in‑charge role.
  • Hands‑on knowledge of reactors, centrifuges, filters, dryers (FBD, VTD, RCVD), distillation and solvent recovery.
  • Strong understanding of cGMP, GDP and data integrity (ALCOA+).
  • Exposure to WHO‑GMP, EU‑GMP or customer audits preferred.
  • Good communication in English, Gujarati and Hindi.

Required skills

  • Operation of reactors, centrifuges, filters and dryers (FBD, VTD, RCVD).
  • Distillation and solvent recovery processes.
  • cGMP and GDP compliance.
  • ALCOA+ data integrity practices.
  • WHO‑GMP and EU‑GMP audit readiness.

What we offer

  • Attractive compensation commensurate with experience.
  • A leadership role in a growing, quality‑focused organization.
  • Direct exposure to scale‑up, new product introductions and regulated‑market audits.

Questions fréquentes

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Published 5 hours ago

Expires 1 month from now

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TIVAN SCIENCES PRIVATE LIMITED

Rajkot