Job Description
Title: Officer, Production (Sterile Unit)
Company Name: US FDA Approved Leading Pharmaceuticals Company
Vacancy: --
Age: at most 35 years
Location: Gazipur
Salary: Negotiable
Experience:
∎ 2 to 4 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies, Healthcare/Lifestyle product
Published: 27 May 2025
Education:
∎ M. Pharm or B. Pharm (5 years Professional Degree) from reputed university.
Requirements:
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.
∎ 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.
∎ 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
Company Information:
∎ US FDA Approved Leading Pharmaceuticals Company
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Application Deadline: 7 Jun 2025
Category: Others
