Job Purpose :
Provide front line support for all process-specific issues to production, continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs and applicable guidelines. Represent the manufacturing process, end to end.
Major Accountabilities :
Shop Floor Support
- Provide front line technical and procedural support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
- Provides latest information regarding best practices, investigation findings, CAPAs, MST/TRD experiences to manufacturing SMEs
Business Process & Improvements
- Identifies opportunities for process, operational, and quality improvements for manufacturing
- Execute process technical batches to generate sufficient process knowledge by thoroughly testing critical variables.
- Identifies opportunites for batch record improvements and efficiencies.
Deviations, Investigations, and CAPAs
- Supports investigations, CAPAs, and CAPA effectiveness checks related to process within required timelines
- Ensures all CAPAs are implemented through GMP systems (e.g. MBR revision, training, etc.)
- Use process knowledge to analyze data to provide process understanding, and to identify and investigate root causes of product and process failures
- Open deviations within required timeframes
- Author investigations and support resolution of product complaints, Out Of Expectation, Out Of Specification, Out of Tolerance results
- Use process knowledge and root cause investigation tools to identify root causes of product and process deviations.
- Supports documentation of experimental plan, execution, and results to support investigations
- Ensures robustness (complete, accurate and defendable) of all critical and major investigations
- Author and execute any experiments or runs to support investigations.
- Work cross-functionally to assess and analyze deviations and investigations to determine impact
- Work cross-functionally to ensure production continues in a compliant manner in the event of a deviation and document accordingly.
- Provide timely support for process technology transfer activities
- Provides the necessary training and support to the Operating team
- Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit
Key Performance Indicators :
- Opening of deviations within required timeframe
- Closing of investigations and CAPAs within required timeframe
- Effective CAPAs
- Success rate of internal audits and Health Authorities inspections.
Dimensions of the Job :
- Number of staff reporting : Direct : none
- Financial responsibility (Budget, Cost, Sales, etc.) : Operational Budget: none
- Impact on the organisation :
- Contribute to Site Manufacturing financial /business goals.
- Minimize rejected batches and write-offs.
- Maximize Yield improvements.
Ideal Background :
- Education (minimum/desirable) :
- BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
- Desirable MSc. or equivalent experience.
- Languages : Fluent in English
- Relevant Experiences :
- Minimum 3 years experience in GMP manufacturing role on the shopfloor and/or QA/QC.
- Proven process understanding (Pharma, GMP, Regulatory aspects).
Novartis Competencies :
|Leadership Standards||Fundamental||Intermediate||Advanced||Thought Leader|
|1. Sets Clear Direction & Aligns Team & Others Around Common Objectives||X|
|2. Energizes The Team|| X|
|3. Display Passion For The 3Cs||X|
|4. Exercises Good Judgement & Drives Change For Competitive Advantage||X|
|5. Drives For Superior Results & Has Passion To Win||X|
|6. Builds The Talent Pipeline||X|
|7. Inspires Continuous Improvement & Breakthrough Thinking||X|
|8. Displays Analytical & Conceptual Thinking||X|
|Functional Competencies||Fundamental||Intermediate||Advanced||Thought Leader|
- Manufacturing process science
- Manufacturing process technologies
|Lominger Competencies||Fundamental||Intermediate||Advanced||Thought Leader|
- Functional/Technical Skills