Bachem Holding AG Deutschlandweit vor 1 Monaten

Senior Commissioning & Qualification (C&Q) Lead (f/m/d), 100%

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Das ist der Job

The company is listed on the SIX Swiss Exchange.

Darum lohnt es sich

Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia.

HVAC, media systems); automation and CSV experience is an advantage /li liExcellent written and spoken German and English /li /ul h3bBenefits /b /h3 ul liA dynamic and rapidly growing work environment with internal development and training opportunities /li liFlexible working hours with home office days and an option for obtaining additional vacation days through workload reduction /li liCompany‑run daycare center on the Bachem Campus in Bubendorf /li li60% coverage of pension fund contributions by Bachem AG as well as option for extra‑mandatory pension provision with our Pension Plan Plus /li liAccess to benefits platforms with discounts from external partners /li liFresh, healthy and varied food in our staff restaurant /li liA wide range of free sports activities on the Bachem Campus /li /ul pWe welcome applications from all candidates. ppBachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides.

With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services.

For further information, see /p h3bResponsibilities /b /h3 ul liLead and manage commissioning, qualification, and validation activities for pharmaceutical facilities, utilities, equipment, automation, and computerized systems /li liDevelop and implement CQ strategies, CQ Master Plans, and risk-based qualification approaches /li liAuthor, review, and approve GMP documentation including URS, risk assessments, IQ/OQ/PQ protocols and reports /li liEnsure compliance with GMP regulations and internal quality standards /li liAct as the primary CQ interface to Quality Assurance and support regulatory inspections and audits /li liCoordinate cross-functional stakeholders and manage external vendors and CQV consultants /li liMonitor progress, manage risks, deviations, and change controls, and provide transparent reporting to project leadership /li liDrive standardization, continuous improvement, and best practices across CQ activities /li /ul h3bQualifications /b /h3 ul liBachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline /li liExtensive experience in Commissioning Qualification / Validation within the pharmaceutical industry /li liProven track record of leading CQ activities on large scale GMP capital projects /li liStrong knowledge of GMP regulations (EU/FDA), ISPE guidelines, and risk based qualification methodologiesExperience with facilities and utilities (e.g.

What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation. /p pPlease note: unsolicited resumes from recruitment agencies will not be considered. /p /p #J-18808-Ljbffr

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