Lowongan Kerja Cimanggis Posisi Qc Manager di PT Bayer Indonesia

JOB PURPOSE

• As Subject Matter Expert (SME) related with the Quality Control (QC) activities, and as Qualified Person (QP) for QC in Bayer Cimanggis site.

YOUR TASKS AND RESPONSIBILITIES

• Check the maintenance of the department, premises and equipment
• Ensure that QC raw data is maintained
• Sampling and Testing
  1. Sampling starting materials, packaging materials, bulk drug products and finished drug products according to approved sampling plans
  2. Test the above listed materials according to approved and validated test methods
  3. Sampling and testing utilities, equipment and environmental systems used for the manufacturing activity.
  4. Initiate and manage stability studies, issue Product Stability Alerts to QA and manage any stability failures
  5. Maintain Reference Standards (primary and secondary)
  6. Manage chemical and microbiological reagent inventory
  7. Storage of reference and retention samples of materials and products
  8. Perform transfer of analytical methods
• Quality Issues

                    a. Create deviation or OOS/OOT reports in case of testing issues

                    b. Participate in the investigation of complaints, deviations, discrepancies etc. related to the quality of the product as well as counterfeit issues

• Qualification and Validation
  1. Ensure that the analytical equipment is qualified, maintained and calibrated
  2. Provide support for preparation of product quality reviews
• Approve and monitor any contract analysts working within the QC unit of the site
• Ensure that the required initial and continuing training of the department personnel (incl. contract analysts) is carried out and adapted according to need.
• Support determination of shelf life/re-test date
• Support maintaining appropriate precaution on occupational safety and health as well as security of facilities within Quality Department.
• Coordinating to evaluate HIRA (Hazard Identification Risk Assessment) of working area and ensure the completeness of HIRA training on the team and implementation of HIRA.

WHO YOU ARE

• Pharmacist with 5+ years’ experience in GMP aspects or related area.
• Be a pharmacist who has completed his service to the Government and owns a work license from local authority for being a responsible pharmacist for Quality Control.
• Be familiar with GMP principles; occupational safety and health, and environmental control and all relevant Government regulations in quality control operations.
• Be able to resist any influence which would hamper management decision.
• Exercise business management of the QC area by up-dating with the latest Bayer standards and up-dated regulations.
• Be able to work in a team and has an ability to encourage others persuasively.
• English and PC literate and has a basic conceptual skill to write down ideas.