Production Manager (pharma/biotech Mfg, Gelang Patah)

Gelang Patah, Malaysia

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Monitor compliance with Good Manufacturing Practice
Ensure batches are manufactured according to production plan
Ensure adherence to standard operating procedures
Responsible for production planning and inventory control
Ensure timely release of batches
Review and submit GMP documents to QA
Investigate non-conforming issues and implement CAPA
Maintain equipment qualification status
Plan for CAPEX and OPEX requirements
Follow company EHS policies and ensure effective implementation
Give objectives and proper utilization of production personnel
Train and evaluate production personnel
Responsibility for continuous improvements and product life cycle management
Ensure availability of personnel and schedule requirements accordingly
Responsible for OTIF execution of activities related to Downstream purification-1 and Buffer Preparation area
Have visibility on SAP operations and get trained on basic requirement

Requirement

Bachelor\'s degree in Chemical Engineering, Pharmaceutical Science, or Biotechnology.
At least 5 years of experience in production or manufacturing, preferably in pharmaceutical or biotech.
Strong knowledge of GMP and quality systems.
Experience with downstream purification, buffer prep, and SAP.
Strong problem-solving and CAPA implementation skills.
Must able to work in Gelang Patah

*A detailed JD will be given upon request. Job Types: Full-time, Permanent Salary: RM6,000.00 - RM10,000.00 per month Schedule:

Application Question(s):

Do you have working experience Production Manager (Pharma/Biotech)? If yes, how many years?
Do you have knowledge of GMP and quality systems?
Do you have experience with downstream purification, buffer prep, and SAP?
Do you have experience in problem-solving and CAPA?
Able to work in Gelang Patah?

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