Officer/Executive- Production Injectables

☞ BDR Pharmaceuticals Internationals Pvt. Ltd.

看过: 107

更新日: 06-05-2024

位置: Vadodara / Baroda Gujrat

类别: 生产/工艺 保养

行业: Pharmaceutical & Life Sciences

水平: Production Manager

工作类型: Full Time, Permanent

经验: 2 - 7 years

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工作内容

  • Execute the operational activities as per plan.
  • To keep respective workplace all time readiness for inspections / audit.
  • To ensure availability of status labelling at respective work place throughout all stages of manufacturing.
  • Follow GMP, GDP and operational SOPs during each activity performed on line. Zero Data Integrity Breach findings in internal and/or External Audits.
  • To maintain discipline in the department.
  • To ensure availability and updation of status labelling at respective work place throughout all stages of manufacturing.
  • Preparation, usage and destruction of disinfectant cleaning solution.
  • Monitoring of Differential pressure, temperature and humidity record of the area.
  • To perform area / equipment, accessories cleaning.
  • Maintaining daily logs like machine log, area and equipment usage cleaning logs etc.
  • To protect product and material against spillage and deterioration.
  • To be involved in compliance with the requirements of cGMP and investigation of factors which may affect product quality
  • Reporting of abnormal observation or deviations to line officer or Department Head.
  • Updation of machine history file.
  • To investigate, record and reporting to quality assurance any problem which may adversely affect the quality of the material/product like damage to containers etc.
  • To ensure assigned responsibilities area cleaning, machine operation at different sections (Dispensing, component preparation and sterilization, load preparation, vial washing and tunnel sterilization, clean room garment handling, batch mfg., filling and sealing, lyo operation, filled container collection area, terminal sterilizer area, transfer of material etc.) and same are documented as per instructions mentioned in SOPs / BMRs during all stages of manufacturing.
  • To take appropriate action promptly to rectify delays.
  • Target Zero batch rejection due to operational failures. Control the process losses in each operation.
  • To ensure cleanliness in the area /section / department by performing area /equipment/ drain points cleaning sanitization and to ensure timely completion of related documentation of same.
  • To ensure machine operations, cleaning and planned preventive maintenance are performed as instructed in respective SOPs
  • Ensure all operations are performed as per safety norms to avoid accidents in plant.
  • Ensure availability and maintenance of PPEs by coordinating with HSE department for requirements and shift schedule.
  • Know and follow aseptic practices and cleanroom behaviour.
  • Any other Job allocated by Production Head/ Unit Head.Roles and Responsibilities




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最后期限: 20-06-2024

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