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12273en
- Contract
- English, German
- Mid-Senior level
- Research & Development
- Basel
- Healthcare & Life Sciences
Skills
Pharma, GMP, QA, QC, CAPAs, Quality Risk Assessment
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This vacancy has now expired
For our client, one of the leading Healthcare & Life Sciences companies based in Basel area, Swisslinx is seeking a highly motivated individual to take on a challenging role as a Process Expert Projects CGT.
Job Title: Process Expert Projects CGT
Duration: 6 months
Your mission:
• Provide front line 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
• Responsible for maintaining the master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment)
• Ensure that all critical parameters are within written Instruction (i.e. Master Batch Record)
• Support steward for assessment of technical changes and process changes (task manager ACC/PCC)
• Act as Change Phase Manager
• Supports and performs Quality Risk Assessment
• Ensure that all process changes are managed through appropriate change control procedure
• Perform first line evaluation of product and process related issues, perform root-cause investigations (deviations, complaints, OOS, OOE) and implement effective CAPAs
• Review validation and qualification protocols and reports for technical correctness
• Support the execution of process validations and qualifications, and short-term improvement projects
• Responsible for creating the master manufacturing documents of assigned products, as appropriate
• Be knowledgeable of process design by providing input during process transfer
• Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables
• Acts as Subject Matter Expert for Audits
The ideal candidate:
• BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree
• Desirable MSc. or equivalent experience
• Minimum 5-7 years of experience in process support role on the shopfloor of GMP manufacturing and/or QA/QC
• Proven process understanding (Pharma, GMP, Regulatory aspects)
• Fluency in English and German language
Job Title: Process Expert Projects CGT
Duration: 6 months
Your mission:
• Provide front line 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
• Responsible for maintaining the master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment)
• Ensure that all critical parameters are within written Instruction (i.e. Master Batch Record)
• Support steward for assessment of technical changes and process changes (task manager ACC/PCC)
• Act as Change Phase Manager
• Supports and performs Quality Risk Assessment
• Ensure that all process changes are managed through appropriate change control procedure
• Perform first line evaluation of product and process related issues, perform root-cause investigations (deviations, complaints, OOS, OOE) and implement effective CAPAs
• Review validation and qualification protocols and reports for technical correctness
• Support the execution of process validations and qualifications, and short-term improvement projects
• Responsible for creating the master manufacturing documents of assigned products, as appropriate
• Be knowledgeable of process design by providing input during process transfer
• Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables
• Acts as Subject Matter Expert for Audits
The ideal candidate:
• BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree
• Desirable MSc. or equivalent experience
• Minimum 5-7 years of experience in process support role on the shopfloor of GMP manufacturing and/or QA/QC
• Proven process understanding (Pharma, GMP, Regulatory aspects)
• Fluency in English and German language
