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15508en
- Contract
- English
- Mid-Senior level
- Engineering & Technical Services
- Switzerland
- Healthcare & Life Sciences
Skills
QA Operations, Pharma, Biotech, Master Batch Records, Change Requests, Documentation, CAPA, Auditing, Validation, Risk Assessment
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About our client:
For our client, a world-leading life sciences company located in the South of Switzerland, Swisslinx is looking for an experienced QA Operations Specialist to act as first contact person for manufacturing projects on quality related topics. This opportunity is open on an initial 6 months contract basis with a possible extension thereafter.
Your responsibilities:
- Acting as first contact person for manufacturing projects on quality related topics
- Reviewing and approving Master Batch Records and checking against filing documents (CMC, BLA), reviewing executed batch records
- Preparing batch release (including documentation) and making recommendation on batch disposition
- Reviewing and approving:
o Process-related Change Requests
o Specifications of Drug Substance
o Process-related Deviation and OOS Investigations
o Process related documents
o CAPAs
o Quality Manufacturing Agreements with shareholders
- Supporting the internal audit program as well as validation activities
- Participating in and authoring Risk Assessments
- Supporting shareholders audits as well as any quality and product impact related enquiry coming from internal stakeholders
Your background:
- 5+ years of QA Operations experience
- Strong experience working in pharma/biotech environments
- Ability to work in a fast-paced environment with great team orientation and independent work skills with a strong work ethic
- Bachelor's degree in Biotech, Chemistry or similar
- Fluency in English
If you are a highly motivated professional looking for an exciting new project within a highly innovative work environment, please apply via the portal or via the Swisslinx website www.swisslinx.com.
For our client, a world-leading life sciences company located in the South of Switzerland, Swisslinx is looking for an experienced QA Operations Specialist to act as first contact person for manufacturing projects on quality related topics. This opportunity is open on an initial 6 months contract basis with a possible extension thereafter.
Your responsibilities:
- Acting as first contact person for manufacturing projects on quality related topics
- Reviewing and approving Master Batch Records and checking against filing documents (CMC, BLA), reviewing executed batch records
- Preparing batch release (including documentation) and making recommendation on batch disposition
- Reviewing and approving:
o Process-related Change Requests
o Specifications of Drug Substance
o Process-related Deviation and OOS Investigations
o Process related documents
o CAPAs
o Quality Manufacturing Agreements with shareholders
- Supporting the internal audit program as well as validation activities
- Participating in and authoring Risk Assessments
- Supporting shareholders audits as well as any quality and product impact related enquiry coming from internal stakeholders
Your background:
- 5+ years of QA Operations experience
- Strong experience working in pharma/biotech environments
- Ability to work in a fast-paced environment with great team orientation and independent work skills with a strong work ethic
- Bachelor's degree in Biotech, Chemistry or similar
- Fluency in English
If you are a highly motivated professional looking for an exciting new project within a highly innovative work environment, please apply via the portal or via the Swisslinx website www.swisslinx.com.
