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DRUG SUBSTANCE - DSP1 & BUFFER PREP

  • Full Time, onsite
  • Biocon Sdn Bhd
  • Johor Pharmaceuticals & Medical Devices (Healthcare & Medical) Full time, Malaysia
Salary undisclosed

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Responsibilities:

  • Being the shift in charge, act as a first responder to production questions, issues and concerns
  • Take charge from previous shift along with duly filled records, supervise the activities in the respective shift, review the batch record, log books and other records, guide the shift personnel to ensure the activities and records are falling in line with GMP requirement
  • To ensure the planning and delegation of shift activities to the subordinates
  • Check and ensure the area, equipment and other accessories are in clean state. Get them cleaned with the help of house-keeping personnel
  • To ensure the instructions relating to production operations are strictly followed
  • To perform and document operations in accordance with cGMP. Monitor the compliance with the requirements of Good Manufacturing Practice.
  • To update the real time data entry in BMR’S, CKL, LS, ECC, log books and other documents in DSP1
  • To ensure the availability of buffers and Raw materials for the shift activities.
  • Check for availability of labelling with due information in raw materials, buffers, tools, carboys and miscellaneous items present in the area
  • Maintain the area and equipment with the help of Engineering and maintenance and Instrumentation department. Follow up on activities and issues related to these department
  • To execute equipment qualification protocols and validation protocols.
  • To comply with EHS policies and procedures. To ensure safety practices are followed by all shift personnel and contract labours throughout the shift
  • To ensure the completion of documents and shift activities before hand over to the succeeding Shift in charge.