QC Manager
YOUR TASK & RESPONSIBILITIES
Sampling of API raw materials, API intermediates, APIs, starting materials, packaging materials, bulk drug products and finished drug products according to approved sampling plans (delegation of sampling to productionpersonnel is possible as long as quality oversight is given).
Testing of the above listed materials according to approved and validated test methods.
Sampling and testing related to utilities, equipment and environmental systems usedfor the manufacture of APIs and Drug Products (delegation of sampling to production personnel is possible as long as quality oversight is given).
Creation of deviation or OOS/OOT reports in case of testing issues.
Ensuring that any changes, that have the potential to impact upon quality, safety or effectiveness, and deviations from approved instructions and procedures in Quality Control are recorded and investigated.
Ensuring that the analytical equipment is qualified, maintained and calibrated
Performing validation of analytical methods.
Testing of in-process samples (for API production, ICH Q7 chapter 8.33 applies).
Checking of the maintenance of the department, premises and equipment.
Validation/verification of analytical test procedures.
Initiation and management of stability studies, issue Product Stability Alerts to QA and to management for any stability failures.
Maintaining Reference Standards (primary and secondary).
Ensuring that QC raw data is maintained.
Management of chemical and microbiological reagent inventory.
Management retention sample.
Providing support for preparation of product quality reviews.
Participation in the investigation of complaints, deviations, discrepancies etc. related to the quality of the product as well as counterfeit issues.
Transfer of analytical methods.
Approving and monitoring of any contract analysts working within the QCunit of the site
Initiation on going stability study and management of stability studies, issue alerts to QA on the stability data fully managed by QC and manage stability failures.
Maintaining reference standards.
Ensuring that QC raw data is maintained.
Management of chemical and microbiological reagent inventory.
Management retention sample.
Providing support for product quality review
Participating in the investigations of complaints, deviations, discrepancies etc. related to the quality of the product as well as counterfeit issues.
Ensuring that the required initial and continuing training of the department personnel (incl. contract analysts) is carried out and adapted according to need.
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 areaand 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 andowns 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.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice.
Application Period:
27/05/2021
Reference Code:
405945
Division:
Consumer Health
Location:
Indonesia : DKI Jakarta Jakarta : Cibubur Jakarta
Functional Area:
Quality
Position Grade:
VS 1.2
Employment Type:
Regular
Work Time:
Flexi Hours (8 working hours)
Contact Us
Address
Telephone
E-Mail
Menara Astra, 33rd floor
Jl. Jend. Sudirman Kav.5-6, Jakarta 10220, Indonesia
+622130491111
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