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
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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
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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