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Production Head - Api

18-25 years
Not Disclosed
10 April 22, 2025
Job Description
Job Type: Full Time Education: M.Sc. (Chemistry) / B.E. (Chemical) / B.Tech (Chemical) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Production Head - API
Position: DGM Production | Grade: G8

Location: [Not specified]
Company: [Not specified]
No. of Positions: 1

Qualification:

  • M.Sc. (Chemistry) / B.E. (Chemical) / B.Tech (Chemical)

Experience:

  • 18-25 years of experience in Production API plant.

Job Profile:

  • Review technology transfer documents from R&D and ensure assimilation by production personnel for successful implementation of new products and technologies in the plant.

  • Plan and execute manufacturing activities according to schedule and budget, optimizing plant capacity.

  • Ensure sustainable quality production with optimum plant capacity utilization.

  • Coordinate with the engineering department for preventive maintenance scheduling to reduce or avoid unplanned breakdowns.

  • Collaborate with the Purchase and Planning departments to ensure timely delivery of goods.

  • Ensure compliance with wastewater disposal as per in-house policies.

  • Foster a disciplined workforce and staff development to meet planned growth goals.

  • Develop and implement innovative practices to enhance productivity and improve work culture.

  • Adhere to cGMP as per ICH guidelines related to the job role.

  • Ensure compliance with GxP practices (Good Documentation Practices, Good Laboratory Practices, Good Engineering Practices, Good Warehouse Practices) at the site.

  • Review batch process records, Standard Operating Procedures (SOPs), and cGMP documents, addressing deviations, change control, and out-of-spec (OOS) issues.

  • Implement and follow safety instructions and practices.

  • Ensure HAZOP (Hazard and Operability) studies are conducted for operations with potential risk implications.

  • Control emissions from the plant within acceptable limits.

  • Recommend the work permit system for activities such as Hot Work and Vessel Entry Permits by user departments.