Job Responsibilities
- Assist, organize, direct, and run optimal day-to-day production operations to meet the plan, procedures, and company standards.
- Ensure smooth daily production operations and be responsible for achieving production targets and maintaining product quality.
- Develop schemes and calculate the number of tools and materials needed for the production process.
- Supervise the production of biologic preparation products from semi-finished to finished products, including aseptic preparation and decontamination processes.
- Evaluate the production process, record production results, and document production batches.
- Create and review performance reports and ensure timely submission to the quality team for product release and inventory updates.
- Supervise equipment operation, cleaning, maintenance, and sterilization of production rooms.
- Address and resolve problems during production, perform root cause analysis, and implement corrective and preventive actions.
- Investigate customer complaints related to manufacturing faults, identify root causes, and implement corrective actions to prevent recurrence.
- Prepare documentation such as Manuals, SOPs, WIs, WOs, and FRs in compliance with CPAKB, ISO 13485, ISO 9001, and ISO 17025 standards.
- Conduct training, assessments, and safety programs for production personnel.
Requirements
- Passionate about preserving Indonesia's biodiversity through sustainable innovations.
- Bachelor's degree in Pharmacy, Veterinary, Industrial Engineering, Technical Engineering, Biology, Biomedical Engineering, or Electromedical Engineering.
- At least 5 years of experience in the medical device/vaccine/veterinary drugs manufacturing industry, with a minimum of 3 years in a supervisory role; managerial experience is an advantage.
- Knowledge of CPAKB, CPOIB, CPOHB, ISO 9001, and ISO 13485 standards.
- Experience with molecular biology techniques and in the biotechnology industry is advantageous.
- Proficient in computer skills, including Google Workspace or MS Office.
- Strong teamwork, communication, interpersonal, problem-solving, and leadership skills.
- High integrity, honesty, organization, attention to detail, and dynamic personality.
- Experience in molecular biology techniques is an added value.
Additional Job Responsibilities
- Prepare documentation such as Manual, SOP, WI, WO, and FR according to relevant standards.
- Conduct training, assessment, and safety programs for production staff.
- Supervise staff, promote teamwork, and handle personnel issues including grievances and disciplinary matters.
- Perform people development through coaching and counseling.
- Responsible for production as assigned by the CEO.
- Ensure smooth production operations and achieve targets and quality standards.
- Plan and calculate tools and materials for production.
Only shortlisted candidates will be contacted.
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