Quality Systems Coordinator
Kelly Scientific Resources (KSR), a division of Kelly Services, is the worldwide leading provider of scientific personnel. Our team in Basel (Switzerland) consists of experts with a solid background in chemistry, pharmacy or biotechnology, as well as several years of consultancy experience.
For our customer, an internationally leading pharmaceutical company with headquarters in Basel (Switzerland), we are looking for an experienced
Quality Systems Coordinator
Key Responsibilities and Tasks:
- Supports the Quality Systems function with responsibilities for the implementation of new electronic systems and quality processes, oversight of internal/External audits, change management, training, documentation, and Quality relevant IT systems.
- Leads cross functional teams with responsibility of continuous assessment of Quality Systems performance, uses risk management tools and recommends remediation plans while maintaining product supply and regulatory compliance
- Makes technical decisions and oversees the process for change control, deviation and CAPA management, complaint, supplier qualification, quality risk management.
- Establishes appropriate KPI and trending analysis relevant to business process. Consolidates and makes recommendations.
- Participates on teams to provide highly scientific evaluation of issues intended to mitigate business, product quality, and compliance risk.
- Implements processes that ensure adherence to global quality requirements.
- Maintains awareness of current GMP trends and manufacturing processes and provides input to global procedures and directives.
- Supports the management of continuous improvement within the Quality Unit.
- Interacts directly with external (CMOs and Suppliers) and internal customers.
- Conduct audits at relevant supplier sites (internal and external)
- Minimum of 5 years of relevant experience in QA
- Advanced knowledge and experience in biopharmaceutical subject matter areas including: Manufacturing of bulk, intermediates and final containers; Product disposition and release; Product inspection and labeling; Aseptic processing; Environmental monitoring; Contract manufacturing
- Broad cGMP experience and knowledge, QA/QC and regulatory compliance (US and other international agencies).
- Ability to streamline business processes to maximize efficiencies to resolve discrepancies and trending issues. Must be able to make tough decisions under pressure and be able to adapt to changes in organization structure.
- Strong leadership and interpersonal skills.
- Excellent communication skills, good presentation and influencing skills.
- Ability to effectively manage multiple, complex priorities.
- Ability to work cooperatively in teams and peer relationships.
End of 2018, prolongation likely Starting date:
Basel (some travel might be required)
If you are interested in this career opportunity then please do not hesitate to apply directly online on www.kellyservices.ch or to send your complete application documents to us, preferably this very day! Contact: Diana Steinhauer: diana.steinhauer(at)kellyservices.ch
We are looking forward to getting to know you!