QA Operation

Bayer; Cimanggis; On-site; IDR 150.000.000 - 220.000.000; Full time

Job summary

Bayer seeks a qualified QA Oversight professional at their Cimanggis site, tasked with ensuring compliance with GMP, safety, and halal regulations in pharmaceutical production. The role demands a pharmacist degree, experience in GMP, and the ability to lead continuous improvement projects within QA.

Qualifications

• 5+ years of experience in GMP or related areas.
• Deep knowledge of GMP principles for pharmaceutical products.
• Able to handle QA improvement projects.

Responsibilities

• Perform batch disposition and ensure GMP compliance.
• Coordinate non-conformity management and conduct investigations.
• Oversee quality activities and track corrective actions.

Skills

Pharmacist

GMP knowledge

Occupational safety knowledge

Professional English skills

Education

Pharmacist degree

Job description

MAJOR TASKS

• Perform batch disposition activity within the Cimanggis site, ensuring that the batches have been produced in compliance with the marketing authorization and GMP/GDP requirements.
• Coordinate handling of non-conformity management related to deviations, complaints, out-of-specification issues, and defects from suppliers, including ensuring that investigations are conducted according to the timeline to determine the root cause and define actions.
• Ensure daily activities are performed effectively and efficiently in accordance with current regulations in Quality (GMP, GDP), Safety, food safety, and halal systems.
• Perform QA oversight activities on the shop floor to ensure GMP compliance, food safety, and halal compliance, particularly by coordinating the oversight of the frozen schedule.
• Ensure tracking of the completion of corrective and mitigation actions related to non-conformity issues in the Cimanggis area to maintain high product quality and manufacturing compliance.
• Ensure the implementation of corrective and preventive actions (CAPA) on the shop floor and evaluate their effectiveness to avoid the recurrence of non-conformity issues.
• Evaluate the recurrence, patterns, and trends of non-conformity issues as part of the quality management review and develop the mitigation action plan for continuous improvement.
• Responsible for reviewing and approving the environmental monitoring results and handling the environmental monitoring trend report according to valid procedures.
• Provide quality management review reports on a periodic basis under the QA Operation area.
• Review, approve, and perform the activation/deactivation of the BoM (Bill of Material).
• Coordinate risk management handling within the site, including RA (risk assessment) content review related to quality aspects for non-Operation Areas.
• Support maintaining appropriate precautions for occupational safety and health, as well as security of facilities within Product Quality Assurance activities, and coordinate internal audits.
• Coordinate the evaluation of HIRA (Hazard Identification Risk Assessment) of the working area and ensure the completeness of HIRA training for the team and the implementation of HIRA.
  
  

Skills & Requirements

• Pharmacist
• 5+ years of experience in GMP aspects or related areas.
• Deep knowledge of international and local GMP principles for the manufacturing of pharmaceutical products, food supplements, and halal management.
• Knowledge of occupational safety, health, and environmental requirements.
• Understand current GMP as well as other relevant national and international regulations for pharmaceutical products (GMP codes).
• Familiarity with GMP policies and directives through training to enable controlling implementation into local practices.
• Knowledge of international and local GMP principles for the manufacturing of pharmaceutical products, food supplements, and halal management systems.
• Skilled in working and able to work within teams and cross-functional teams.
• Professional English skills.
• Able to handle improvement projects related to the QA area.
• Able to resist any influence that would hamper management decision-making during the absence of the QA Operation Lead.
  
  

Application Period: 23/06/2025 Reference Code: 848693

Division: Consumer Health Location: Indonesia : West Java : Cimanggis

Functional Area: Quality Position Grade: R.12

Employment Type: Regular Work Time: Standard

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