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Junior Officer - Production

Bioksha

Sikkim, India · À temps plein

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Expérience
3–4 ans
Salaire
Ouvertures
1
Publié
il y a 3 jours
Mode de travail
Au bureau
Éducation
Bachelor in Pharmacy
CV
Candidature requise

Description de l'emploi

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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