Officer, Production (Sterile Unit)

US FDA Approved Leading Pharmaceuticals Company

US FDA Approved Leading Pharmaceuticals Company

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Summary

• Vacancy: —
• Age: at most 35 years
• Location: Gazipur
• Salary: Negotiable
• Experience: 2 to 4 years
• Published: 27 May 2025

Requirements

Education

M. Pharm or B. Pharm (5 years Professional Degree) from reputed university.

Experience

• 2 to 4 years
• The applicants should have experience in the following business area(s):
  Pharmaceutical/Medicine Companies, Healthcare/Lifestyle product

Additional Requirements

• Age at most 35 years

• Should have at least 2-3 years’ working experience in sterile production unit in any pharmaceuticals company.
• Good knowledge/experience of Production Equipment qualification procedures.
• Eager to take the challenge of working in a new project.
• Incumbent should be creative, hardworking & proficient in team playing.
• Strong communication skill.
• Ability to work under pressure.

Responsibilities & Context

• Supervise and monitor aseptic production operations including equipment setup, batch execution, line clearance, and documentation for various sterile formats (Ampoule, Vial, BFS, PFS).
• Plan, organize, and schedule daily production activities and manpower allocation to meet production targets and operational efficiency.
• Ensure strict adherence to regulatory standards and guidelines.
• Oversee cleanroom operations, enforce gowning protocols, aseptic techniques, and maintain environmental parameters (temperature, RH, pressure differentials, viable & non-viable particulate control).
• Supervise and guide operators and technical staff to ensure adherence to SOPs and batch execution protocols.
• Monitor product quality standards, initiate investigations in case of deviations, and support CAPA implementation.
• Collaborate with QA, QC, Engineering, Validation, Regulatory Affairs, and Warehouse teams to ensure operational harmony and regulatory compliance.
• Ensure plant readiness and actively participate in regulatory inspections and audits conducted by: FDA, EU GMP authorities, MHRA (UK), TGA (Australia), Local Drug Regulatory Authorities.
• Support activities such as media fill simulations, equipment validation, cleaning validation, and process qualification.
• Enforce strict health and safety guidelines, cleanroom hygiene, and emergency preparedness practices.
• Assist in production-related purchasing, vendor communication, and process design improvements.
• Work in rotational shifts and be flexible to extend working hours during audits, validations, and critical batch operations.

Employment Status

Full Time

Job Location

Gazipur

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