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Downstream Manager (Asst/Deputy/Asso)

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Downstream Manager (Asst/Deputy/Asso)

  • Location:

    Johor Bahru

  • Sector:

    Monroe Hospital & Healthcare

  • Job type:


  • Salary:


  • Contact:

    Narrtiyanee (Nani)

  • Contact email:

  • Job ref:


  • Published:

    about 2 months ago

  • Expiry date:


  • Client:

    Monroe Consulting Group

Executive recruitment company Monroe Consulting Group Malaysia's Healthcare Division is recruiting on behalf of a leading MNC in Biopharmaceutical, a company that innovates and revolutionise new solutions for everyday treatment. Our esteemed client has a global presence and manufactures various pharmaceutical products to treat patients across 120 different countries. They are seeking an experienced production engineer for the position of Assistant/Deputy/Associate Manager with their downstream department. The job will be based in Johor Bahru, Malaysia.

Job Responsibilities;

  • Monitor compliance with Good Manufacturing Practice requirements.
  • Ensure batches are manufactured according to production plan and without delays.
  • Ensure adherence to standard operating procedures and that the team follows defined procedures.
  • Responsible for production planning and inventory control to ensure raw material availability prior to batch start.
  • Coordinate DS dispensing and ensure timely release of batches.
  • Review and submit GMP documents to QA as per SLA.
  • Investigate non-conforming/Deviations/OOS/OOT and implement CAPA, ensuring timely closure of associated documents.
  • Maintain qualified status of all production equipment in coordination with CFT.
  • Plan for CAPEX and OPEX requirements.
  • Initiate, coordinate, and verify CAPA taken against nonconformance observed during audits.
  • Guide team members in preparation of hazard and risk assessment register, aspect/impact register, and review adequacy.
  • Follow established company procedures and policies pertaining to EHS and ensure effective implementation of EHS management system. Review progress/status of EHS objectives and targets periodically.
  • Responsible for giving objectives and proper utilization of production personnel.
  • Train and evaluate production personnel to minimize manual errors.
  • Establish product life cycle management through validation cycle and continuous improvements towards high throughput. Maintain quality and robustness of the process.
  • Involved in all activities related to Downstream Purification-1, Downstream Purification-2, and Buffer Preparation Area as an additional responsibility.


  • Diploma/Degree Engineering, and related discipline or equivalent.
  • Preferably more than 6 years of downstream experience.
  • HACCP and CGMP experience are a must.
  • Cleanroom experience is a must.
  • Good problem solving, communication and analytical skills.
  • A strong team player with good planning and interpersonal skills.
  • Excellent analytical abilities and creative problem-solving skills.