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Junior Officer - Production

Bioksha

Sikkim, India · На постоянной основе

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Опыт
3–4 года
Зарплата
Открытия
1
Опубликовано
1 зона
Режим работы
В офисе
Образование
Bachelor in Pharmacy
Резюме
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Описание работы

About the Role

The Junior Officer in Production will oversee and execute manufacturing activities within a shift, ensuring adherence to current Good Manufacturing Practices (cGMP) and safety protocols. The goal is to meet production targets efficiently while maintaining quality standards.

Key Responsibilities

  • Carry out assigned production tasks during shifts to achieve set targets.
  • Optimize resource and consumable usage to minimize costs and improve area efficiency by minimizing equipment downtime.
  • Maintain standard process parameters based on Batch Manufacturing Records (BMRs) and related documents to assure production and quality goals.
  • Enforce compliance with GMP and safety norms by reviewing processes and documentation, as well as maintaining equipment and facilities per regulatory standards.
  • Update and manage system documentation, including recording deviations and performing validation, qualification, and calibration activities according to schedules.
  • Prepare and update GMP-compliant manufacturing records and operate relevant software such as SAP, CipDox, and Quality Management Systems (QMS).
  • Ensure safe work practices and proper use of safety gear throughout production shifts by coordinating with the Health, Safety, and Environment (HSE) department.
  • Manage direct reports (approximately 12) and oversee operations across three manufacturing areas involving two dosage forms.
  • Collaborate continuously with departments including QA/QC, Engineering, Formulation Technical Support and Technology Transfer, Stores and Warehouse, Safety, maintenance contractors, and equipment manufacturers to address production, quality, and maintenance issues.

Challenges

  • Meeting shift production targets despite resource limitations through efficient workload distribution and resource optimization.
  • Ensuring smooth knowledge transfer between shifts to avoid production lapses.
  • Maintaining cGMP compliance during system downtimes via coordination with engineering and technical support teams.

Performance Metrics

  • Manage approximately 35-40 production batches monthly.
  • Support around 2 technology transfer projects per month.
  • Achieve over 90% On Time In Full (OTIF) delivery internally.
  • Year-over-year improvement in shift efficiency and zero reportable manufacturing accidents.
  • Reduce batch failures and eliminate errors in online documentation.
  • Ensure full compliance with Standard Operating Procedures (SOPs) and safety regulations.

Education and Experience Requirements

  • Bachelor's degree in Pharmacy.
  • At least 3 to 4 years of work experience including 2 years within pharmaceutical manufacturing.
  • Strong understanding of cGMP practices and operational knowledge of formulation production equipment.

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