Production Head - Api

18-25 years

Not Disclosed

India Remote

10 Feb. 11, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Production Head - API

Date: February 7, 2025
Position: Deputy General Manager (DGM) – Production
Grade: G8

JOB SUMMARY:

The Production Head - API is responsible for overseeing and managing all aspects of API (Active Pharmaceutical Ingredient) manufacturing. The role ensures efficient technology transfer, process optimization, and adherence to production schedules while maintaining regulatory compliance, safety standards, and operational excellence.

KEY RESPONSIBILITIES:

Technology Transfer & Process Implementation:

Review technology transfer documents received from R&D and ensure proper assimilation by production personnel.
Implement new products and technologies in the plant, ensuring smooth transition and execution.

Production Planning & Execution:

Plan and execute manufacturing activities as per the defined schedule and budget.
Optimize plant capacity utilization to ensure sustainable quality production.
Coordinate with purchase and planning departments to ensure timely delivery of goods.

Equipment & Engineering Coordination:

Work closely with the engineering department to schedule preventive maintenance and minimize unplanned breakdowns.
Ensure all equipment functions optimally to support continuous production.

Compliance & Documentation:

Ensure compliance with cGMP, ICH guidelines, and GxP practices, including:
- Good Documentation Practices (GDP)
- Good Laboratory Practices (GLP)
- Good Engineering Practices (GEP)
- Good Warehouse Practices (GWP)
Review and approve batch process records, standard operating procedures (SOPs), and cGMP documents.
Investigate deviations, change controls, and out-of-specification (OOS) results.

Environmental & Safety Compliance:

Ensure proper wastewater disposal in compliance with in-house policies and regulatory guidelines.
Oversee HAZOP (Hazard and Operability) studies for risk-prone operations.
Monitor and control plant emissions within acceptable limits.
Implement and enforce safety instructions and best practices across production activities.
Ensure work permit systems (e.g., hot work, vessel entry permits) are recommended and followed.

Workforce Development & Continuous Improvement:

Develop a disciplined and skilled workforce to meet planned production goals.
Implement innovative practices to enhance productivity and work culture.
Promote a culture of continuous improvement and operational excellence.

JOB REQUIREMENTS:

Educational Qualification:

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

Experience:

18-25 years of experience in API plant production.

Skills & Certifications:

Strong understanding of API manufacturing, technology transfer, and production management.
Expertise in cGMP, ICH guidelines, and GxP practices.
Knowledge of HAZOP studies, emission control, and safety regulations.
Excellent leadership, coordination, and problem-solving skills.

Join us to lead API production with innovation, efficiency, and regulatory excellence!

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