Are you a QA professional interested in working for one of the most interesting names in High-Tech Biotech in Swiss Romande?
A challenging contract role has just opened at one of our leading clients offering a passionate quality specialist an opportunity to join a versatile team of professionals working on exciting projects in the biopharmaceutical manufacturing.
Site Readiness QA Specialist
* QA Operations:
o QA support for implementation of Manufacturing execution System (MES) implementation
o Review and approve MBRs, specifications and Material Master data
o Review executed batch records
o Manage deviations, CAPA and Change controls
o Support Risks assessments
o Support the creation and review of operational procedures,
* Raw Materials' Management:
o Conduct Supplier's audits
o Support establishment of Raw materials specification
o Review and approve Raw Material Master data
o Release Raw Materials
o QA oversight of Raw Material analytical method validation
* Quality Systems:
o Develop and compile quality metrics and Dashboards
o Conduct periodic trainings on electronic systems
o Support the Quality Systems initiatives
* Act within compliance and legal requirements as well as within company guidelines
* Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees
* At all times work in a right first time and site readiness approaches for regulatory inspections (Swissmedic and International)
* Contribute positively to a strong culture of business integrity and ethics
* Bachelor's Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing
* Speak, read and write in French and English
* Minimum of 3 years in a Quality Assurance role in a biopharmaceutical manufacturing environment
* Good knowledge of biotechnology processes and manufacturing
* Qualified auditor is a plus
* Demonstrated proficiency in cGMP as well as biopharmaceutical industry regulations.
* Proficiencies with the quality systems and electronic systems.
Are you interested? To apply for this vacancy, just use the button ‘Apply' and complete application documents (cv, job references and proof of qualification) with your notice period and salary expectations. Please note that only online applications will be considered.
Manpower Life Sciences is a specialist group within the agency, connecting international and Swiss competent talent with job opportunities in pharmaceutical, biopharmaceutical, biotechnology and medical device companies.