Quality Assurance Manager 100% (m / f / d)
Company information
Solvias is an internationally recognized provider of integrated solutions in contract analytical research, development and manufacturing. The company offers a broad spectrum of services and solutions in the Pharmaceutical, Biotech, Medical Device, Cell & Gene Therapy and Cosmetic industries. With headquarters near Basel, Switzerland, over 800 highly qualified employees take pride in putting science at the heart of serving customers to bring safer and better products to market faster.
Responsibilities
* Ensure documentation supporting site quality processes is clear, compliant, and acceptable for use in a GMP testing environment
* Drive deviations, non-conformities, OOS investigations to closure and ensure adherence to procedures; this includes but is not limited to ensuring effective root cause analysis has been conducted, collaborating with stakeholders on suitable corrective and preventive actions, and ensuring that conclusions are supported with adequate information and a clear rationale
* Own and coordinate or act in approver capacity for change controls
* Support GMP training for peers and stakeholder teams
* Monitor and report on metrics and KPIs; collaborate with stakeholders to improve quality process efficiency and effectiveness
* Support the Quality Assurance organization in the coordination of, preparation for, and follow up on internal and external audits and inspections
Requirements
* Bachelor in Life Sciences with 5+ years relevant experience in a quality-facing role (or equivalent combination of education and experience)
* Experience working in GMP testing environment
* Experience in processing quality events (i.e., deviations, laboratory non-conformities, OOS / OOT / OOE investigations, CAPAs, change controls) per applicable operating procedures
* Experience supporting internal or external audits and health authority inspections
* Working with QMS (e.g., MasterControl) and LIMS (e.g., Labware) IT systems
* Have a developing subject matter expertise in one of the following areas of the QMS : controlled document management, GMP training program management, data integrity program management, audit / inspection management
* Excellent organizational skills and ability to work and make decisions independently
* Strong written and verbal communication skills
* Fluency in English and willingness to learn German is required
* Comprehensive onboarding to ensure a smooth start
* Flexible working models with a 40-hour workweek and at leastvacation days annually
* Diverse opportunities for professional development and career growth
* Attractive pension plans and commuter subsidies for public transport users
* Generous family benefits, including above-average child allowances and voluntary family support
* Access to discounts via a voucher platform and subsidized Reka-Checks
* An excellent on-site cafeteria
Our employees are very close to our hearts. Each individual can make a difference and develop both professionally and personally. Does this appeal to you? We are looking forward to receiving your online application. Apply now SOLVIAS AG jidaae5e93a jit1042a jiy25a
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