Process Technical Support
Abbott
**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 transferProcess Trial & ValidationProcess 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.
**C** **ontributing 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
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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