CHE - 8262 Baxalta Manufacturing Sarl
Quality Systems Specialist - Documentation(m/w/x)
Full-timeOn-siteExperienced
Neuenburg
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Equipment validation and qualification for clinical trial operations, applying cGMP and risk-based C&Q strategies. 1+ year pharmaceutical industry experience and cGxP knowledge required. Global clinical trial focus.
Requirements
- BS/MS in Engineering/Technical discipline or equivalent experience
- Minimum 1 year of experience in the pharmaceutical industry
- Strong knowledge of international regulatory regulations, cGxP requirements, and best practices
- Proactive and collaborative communication skills
- Problem identification and solution recommendation skills
- Team player with effective interaction skills
- Good level of English
- Ability to communicate in French preferred
Tasks
- Perform validation and qualification activities
- Ensure compliance with cGMP and internal policies
- Develop and justify the C&Q approach based on risk and scientific rationale
- Manage continuous improvement topics in equipment risk analysis
- Lead risk assessments and periodic review activities
- Ensure qualification and validation of equipment and systems
- Author and review qualification documents as needed
- Execute re-qualification and periodic review activities
- Contribute to the development of local site procedures
- Review change controls and maintenance interventions
- Coordinate qualification and validation execution activities
- Participate in internal and external audits as a subject matter expert
- Establish effective relationships with internal teams, customers, and suppliers
- Proactively identify problems and propose solutions
- Complete work independently while seeking guidance on complex tasks
- Participate in projects and initiatives as directed
Work Experience
- 1 year
Education
- Bachelor's degree
Languages
- English – Business Fluent
- French – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bristol Myers Squibb and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Equipment validation and qualification for clinical trial operations, applying cGMP and risk-based C&Q strategies. 1+ year pharmaceutical industry experience and cGxP knowledge required. Global clinical trial focus.
Requirements
- BS/MS in Engineering/Technical discipline or equivalent experience
- Minimum 1 year of experience in the pharmaceutical industry
- Strong knowledge of international regulatory regulations, cGxP requirements, and best practices
- Proactive and collaborative communication skills
- Problem identification and solution recommendation skills
- Team player with effective interaction skills
- Good level of English
- Ability to communicate in French preferred
Tasks
- Perform validation and qualification activities
- Ensure compliance with cGMP and internal policies
- Develop and justify the C&Q approach based on risk and scientific rationale
- Manage continuous improvement topics in equipment risk analysis
- Lead risk assessments and periodic review activities
- Ensure qualification and validation of equipment and systems
- Author and review qualification documents as needed
- Execute re-qualification and periodic review activities
- Contribute to the development of local site procedures
- Review change controls and maintenance interventions
- Coordinate qualification and validation execution activities
- Participate in internal and external audits as a subject matter expert
- Establish effective relationships with internal teams, customers, and suppliers
- Proactively identify problems and propose solutions
- Complete work independently while seeking guidance on complex tasks
- Participate in projects and initiatives as directed
Work Experience
- 1 year
Education
- Bachelor's degree
Languages
- English – Business Fluent
- French – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bristol Myers Squibb and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Bristol Myers Squibb
Industry
Pharmaceuticals
Description
The company is dedicated to transforming patients’ lives through science and promotes global participation in clinical trials.
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