Process Technical Support

Primary Function:

• Site SME for process technology, product life cycle and problem solving for pharmaceutical processes of products manufactured in Abbott Cimanggis Site.
• Contributes to the complex projects i.e., product transfer, and technology implementation in collaboration with Production, Quality, Bex and regional team.
• Support other department in technical activities in compliance with cGMP and respective BOPs & EHS with efficient and cost effectives include but not limited to: Product transfer Process Trial & Validation Process improvement

Major Responsibilities:

Process Validation & Product Life Cycle (PLC) management

• Periodic review product quality aligns with Periodic Quality Report (PQR), and Continuous Process Verification (CPV) program
• Contribute into new/alternative material evaluation and process validation
• Responsible for new/alternative line equipment establishment related to manufacturing process design and its validation
• Mainly responsible for document preparation (including drafting & monitoring approval) and execution process validation activities
• Active to support coordination and preparation of process validation with related department in timely manner

Product Transfer

• Provide support for execution of product transfer & trial with others related department includes but not limited to:
  • Prepare timeline related product transfer
  • Prepare document related product transfer i.e., TT Plan, Validation and Engineering Study
  • Coordinate with others department to execute the defined timeline
  • Dossier preparation.
  • Launching product preparation

Technical Problem Solving

• Technical problem solving of new product or existing processes, includes but not limited to:
  • Data collection and investigation processes
  • Together with Technical Services Associate Manager to regional MS&T / workstream to escalate any cases could not be resolved locally.
  • Prepare documentation and conduct process optimization & its validation
  • Conduct sharing session/training to production team related to the solution
  • Post improvement monitoring

Documentation Filing

• Maintain all Technical Service Department properties and the confidentiality of Technical Services Document
• Responsible for make sure all validation are documented & filling properly
• Support to ensure easy retrieval of field documentation.

Contributing to continuous improvement program Contributing to compete project for cost saving

Requirements:

• Bachelor's Degree in Pharmacy
• Minimum 3 years of related experience in pharmaceutical plant
• Good communication skills
• Good organization skills