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- ...specifications (URS) and risk analyses (FMEA FRA) Creation and review of the Validation Master Plan (VMP) Participate in the creation and writing of test protocols for commissioning and qualification: FAT/SAT/IQ/OQ/PQ according to GMP requirements Participate in...Suggéré
- ...trial design evidence generation and clinical value of Roche medicines. The Opportunity: As a Data Strategy Annotation and Validation Specialist within the Digital Endpoints and Patient-Centered Solutions (DEPCS) function you will contribute to building scalable...SuggéréTemps plein
- ...revenue) Perform basic variance analysis (Actual vs Plan) Help validate data between ERP and planning tools Support data uploads... ...Help identify simple automation opportunities in Excel Qualifications Currently pursuing a degree in Finance Accounting...SuggéréTemps plein
- ...Oversee the ISS review and approval process, including proposal validation, coordination of reviews, and communication of decisions to... ...-up and management of MAP and PTA programs as needed. Qualifications The ideal candidate must possess: A university degree...Suggéré
- ...projects that are innovative medically relevant scientifically valid and appropriately planned managed executed lead effective... ...per year with several products across the SOBI portfolio. Qualifications : Post-graduate degree in Health Economics Economics Pharmacy...SuggéréTemps pleinRemote job
- ...of test tools, benches, jigs, and rigs for verification and validation Troubleshoot issues related to consumables through hands-on... ...relevant to consumables, materials, and manufacturing techniques Qualifications Bachelor's degree in Mechanical Engineering, Product...SuggéréTemps plein
- ...GMP manufacturing operations. The role will focus on operation qualification troubleshooting and continuous improvement of autoclave and... ...manufacturing Support commissioning qualification (IQ/OQ/PQ) and validation activities Troubleshoot equipment issues and lead root...SuggéréTemps plein
- ...commutable distance to our office in Basel. Position is on site. Qualifications, Knowledge and Skills: * Master Mariner or Chief Officer... ...with European river systems and regulatory frameworks. * Valid certifications and advanced navigation training. * Expert knowledge...Suggéré
- ...experience with Deltav, GAMP, Batch SW application, Validation and Life Science automation experience, MS-Office... ...~ Proficiency in English and German. ~ A valid car driving license. Preferred Qualifications that set you apart: Past experience in...SuggéréTemps plein
- ...Risk Team (BRT) activities including signal detection analysis validation risk management and safety labelling. Contribute to... ...compliance with GVP GCP and worldwide regulatory requirements. Qualifications : Education and Experience: University level qualification...SuggéréTemps pleinRemote job
- ...underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply.... ...matter expert (SME) for drug product (DP) manufacturing and validation. Lead and execute MSAT projects focused on process and...Suggéré
- ...process parameters and quality attributes and supervise process validation campaigns at CDMOs. Author review and approve CMC sections... ...molecule development candidates into clinical development Qualifications PhD or MSc in Pharmacy Chemistry or related scientific...SuggéréTemps pleinAssurance-invalidité
- ...tasked with the design, implantation and validation of automated tests and automation test... ...and establish test protocols to validate these requirements. You will be executing... ...software engineering and DevOps team. Qualifications Bachelor's degree in engineering or...SuggéréTemps pleinRemote jobTravail à domicile
- ...building advanced in vitro models to develop, validate and apply more predictive human lung... ...-on experience with the development, validation and application of complex in vitro... ...and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits...Suggéré
- ...Benefit Risk Team (BRT) including signal detection analysis validation risk management and safety labelling. Provide clinical safety... ...Support audits and inspections related to product safety. Qualifications : Required: University level qualification in...SuggéréTemps pleinRemote job
- ...analytical methods and control systems are validated reliable and compliant throughout the... ...portfolio. Leading the transfer and validation of analytical procedures at commercial... ...at CDMOs and you bring the following qualifications: ~ a B.S. or M.S. degree in a scientific...Temps plein
USD 113500 - USD 210900 par année
...Independently identify and collaborate with PSCLs to understand and validate product supply plan requirements and outcomes. May also... ...- $210900. Actual pay will be determined based on experience qualifications geographic location and other job-related factors permitted...Temps plein- ...Collaboration: Outstanding communication skills and mastery of teamwork in a diverse environment (QA Production QC IT Engineering Validation/Qualification) to drive collaboration with partners. Regulatory Acumen: Strong acumen across relevant GMP regulations (e.g. revised...Temps plein
- ...to develop robust processes for both clinical and commercial production. Quality Validation & Risk Management: Strategy Development: Define Process Performance Qualification (PPQ) and Quality Control strategies. Risk Mitigation: Author and manage risk documentation...Temps plein
- ...user engagement and ensuring compliance with regulated standards. Ensure timely review and approval of critical design qualification and validation deliverables (e.g. technical specifications test documentation) in partnership with Site Engineering Quality Device...Temps plein
- ...BIIEs new Allschwil facility including equipment installation validation and operational readiness. Establish and manage shared... ...settings Experience with laboratory commissioning equipment qualification or facility startup projects preferred Experience supervising...
- ...HRMS GC-MS Headspace-GC-MS ICP-MS IC). Lead the development validation and quantitative determination of Nitrosamine Drug Substance... ...the application of GxP requirements is a plus. Further qualifications are: Proven practical experience in impurity quantification...Temps plein
- ...of the European Union. Key Responsibilities: Develop validate and maintain data models for synthetic molecules biologics and... ...position in the market and consider your previous experience qualifications and individual competencies. Commitment to Diversity &...Temps plein
- ...manufacturability decision through process performance qualification (PPQ) supply maturity and optimization... ...as well as that the product remains validated robust cost-effective and compliant.... ...transfer and/or with process validation and in pharmaceutical quality systems and...Temps plein
- ...opportunity Developing improving and validating analytical methods for quality... ...analytical documents such as procedures validation reports SOPs and regulatory submission... ...official educational certificates/proof of qualifications. No additional documents are required...Temps plein
- ...be at the heart of new plant implementations, overseeing the qualification lifecycle from commissioning through to operational support,... ...environment, specifically in commissioning, qualification, and validation of systems like refrigerators, freezers, clean media, and...Horaire flexible
- ...manufacturability decision through process performance qualification (PPQ) supply maturity and optimization... ...as well as that the product remains validated robust cost-effective and compliant... ...transfer and/or with process validation and i n depth conceptual and practical...Temps plein
- .... ~Develop and implement experimental protocols to test and validate the Labscanner Plus and Authentifield technologies related to... ...presentations on experimental findings and technology assessments. Qualifications and Experience: ~Relevant working/residency permit or Swiss/...
- ...physical and chemical data for materials, developing/improving and validating analytical test methods or other analytical controls and... ...prepare for regulatory submissions such as IND and NDA. Qualifications and Experience: ·Relevant Swiss working/residency permit or...
- ...consistency across implementations. ·Review and validate functional designs, configuration... ...architecture walkthroughs, and design validation sessions. ·Mentor junior team members... ...and workflow architecture. Qualifications and Experience: ·More than 10 years...
