HomeProductionExecutive -Parenteral Manufacturing | Pfizer Ltd | Vizag

Executive -Parenteral Manufacturing | Pfizer Ltd | Vizag

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At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer

Position:  Junior Officer – Manufacturing

Location: Vizag, Andhra Pradesh, India

Job Description:

Technical Skills & Knowledge:

  • Manufacturing of parenteral dosage forms
  • Preferably experiences in good understanding of manufacturing and quality systems
  • Handling, storage, and reconciliation of materials Prior experience in the following
  • Technical knowledge regarding filling and stoppering of Vials
  • Should have knowledge on types and sources of contamination
  • Standards, Process, and Policies
  • CGMP and application of quality management systems
  • Good documentation practices
  • Technical writing and document review skills
  • Ability to write and revise standard operating procedures and related manufacturing documents

Operations:

  • Ensure processing of filling and stoppering as per procedures.
  • Activity planning and deploying the personnel according to the plan
  • Ensure area upkeep with adequate identification of machines and materials
  • Conduct real-time batch record review in assigned area
  • Enforce discipline of the personnel working in the process area
  • Ensure adequate cleaning, sanitization of the equipment and area and housekeeping
  • Ensure avoidance of cross-contamination and/or mix-ups
  • Coordinate supporting functional departments for the smooth operation of production activity
  • Ensure all the performed activities comply with respective procedures.
  • Ensure the completeness of documentation for all performed activities
  • Review of all related protocols (Qualification/ Trial Run Protocols)
  • Initiating CCFs related to documents, equipment. Ensuring their closure and implementation of the changes within the specified time

Quality Management and Compliance

  • Ensure compliance of operations to cGMP, safety, and Hospira integrity principles at all stages
  • of activity

  • To participate in internal & external (Regulatory & Non-Regulatory) audits

Documentation:

  • To prepare the SOPs, Sol’s and SCIs, pertaining to the area in compliance with regulatory requirements/corporate guidelines/practices
  • Ensure to fill/write the documents pertaining to the respective area of work on-line as per CGMP, cGDP and submit the documents to the production documentation cell on time
  • To prepare the daily activity report

Training:

  • To attend the qualified training for all the applicable procedures as per the schedule before performing the job
  • Training the staff on relevant procedures and getting trained in the respective area of work
  • Training the housekeeping personnel as per the requirement.
  • Identify deviations/exceptions and escalate to Manager by appropriate procedures
  • Active participation in the investigations related to exceptions and during equipment maintenances.
  • Disposal of rejects and waste generated during processing and other related activities
  • Initiate and assist with ER investigations as applicable
  • Monitor assigned area for compliance to SOPs and cGMP
  • Adherence to safety procedures/GMP & GDP
  • practices Preparation of trial run protocols related to exceptions.
  • Raise requests to Engineering in the event of breakdown/maintenance – Certify the same after completion

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