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QA System 

  
   
   

PURPOSE

 

As core function for Bayer Cimanggis plant unit on assuring the compliance of Bayer and authority regulations related with GxP, Computerized System Validation (CSV), Qualifications activities, and managing the technical system and computerized system life cycle (including calibration) which consists of but not limited to Commissioning-Decommissioning activities.

 

 

MAJOR TASKS & RESPONSIBILITIES

 

  • Ensure the Technical System lifecycle is implemented according to the updated SOP by performing qualification of technical system and maintain its requalification status.
  • Conduct the review of the technical system lifecycle document consists of B-review, Quality Impact Assessment, URS, Functional Specification, Risk Assessment, Commissioning Document (GMP Relevant), Qualification Document.
  • Coordinating with the technical system owner and project lead according to technical system life cycle activities.
  • Assures all quality aspects are appropriately addressed during GxP Computerized system validation activity.
  • Execute qualification, GxP IT Infrastructure qualification and computerized system validation activities that has been scheduled with timely manner.
  • Conduct review calibration report and create tag calibration status.
  • Conduct periodic review related to Technical System.
  • Execute CAPA related to Technical System and Computerized System Validation.
  • Documenting the implementation and execution of data integrity topics, the life cycle of computerized systems and IT infrastructure related to GxP and Non-GxP systems.
  • Perform evaluation/investigation of deviations results related with the CSV and qualification issue.
  • Local Subject Matter Expert (Local SME) for ValGenesis System (system for qualification and validation activities and documentation).
  • Explore to identify and propose continuous improvement of quality aspect with implementation in QA System area.
  • Upgrade his-self in management and professional skills and including developing team especially on GMP aspects.
  • Support maintaining appropriate precaution on occupational safety and health as well as security of facilities within Quality Department.
  • Coordinating to evaluate OHSERA (Occupational Health Safety and Environment Hazard Identification Risk Assessment) of working area and ensure the completeness of training on the team and implementation of OHSERA.

 

 

KEY WORKING RELATIONS

 

Internal

  • The Incumbent reports to the Quality Lead with regards to QA System matters.
  • Works together with all departments of Cimanggis Site in dealing with qualification and CSV activity.

 

External

  • Works together with functions outside of PT Bayer Indonesia (e.g. Global functions of Bayer AG) as agreed with Quality Lead.
  • Coordination with the global team, other Bayer Factories, System Vendors, Service Providers related to qualification activity, and computerized system validation aspects.

 

 

QUALIFICATIONS & COMPETENCIES

 

  • Pharmacist with minimum 3 years experience in GMP aspects, Quality Assurance.
  • Familiar with international and local GMP principles for manufacturing of pharmaceutical products and food supplements.
  • Team player who is also able to work independently and deliver results with minimal guidance.
  • Pay attention to details and focus to quality of works.
  • Professional English skills and skilled to work within an international team.
  • Good problem-solving abilities.
  • Good organizational and time management skills.
  • Proven flexibility and adaptability.

 

 

 

 
   
Application Period: 19/05/2026 Reference Code: 870336    
Division: Consumer Health   Location: Indonesia : West Java : Cimanggis    
Functional Area: Quality   Position Grade: R.11    
Employment Type: Regular  Work Time: Standard  
 
 
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