A job vacancy for a QA Director has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas. This is a contract QA Director position based in Zurich, Switzerland.
- Lead and manage the Quality Department in Austria and Switzerland
- Act as Quality Representative / Quality Manager to ensure constant compliance with EN ISO 13485, RL 93/42/EWG and local regulation in CH
- Develop, implement and maintain the CH Quality Management System (QMS) covering all necessary GxP, Quality regulations and standards:
- Ensure that the company’s Quality Manual and Division Procedures and Standards are properly deployed into the local QMS and managed accordingly
- Ensure the implementation and enforcement of QMS for the affiliate and GxP suppliers
- Ensure the creation and maintenance of SOPs and their implementation through documented training and inspection activities involving the business units and GxP suppliers
- Gather, maintain and report Key Quality Indicators in accordance with Division QA requirements
- Foster awareness for product quality and safety, compliance with Alcon Quality requirements, and adherence to local regulations:
- Conduct local training for Quality compliance requirements and on quality related subjects as applicable and needed
- Provide input, coordinate and chair Management Reviews and enterprise risk analyses
- Ensure that the Annual Quality Risk Assessment is performed properly and on time
- Prepare, conduct and report internal/ external Quality System audits
- Ensure continuous improvement of the QMS by
- Investigation of quality issues and/or review results provided by other departments
- Investigation of customer complaints related to product quality, when required
- Management of local deviations and Change Control, and escalation of potential issues to Division QA
- Identification, documentation, follow up and closure of Corrective and Preventive Actions (CAPAs)
- Ensure that products are received, stored, handled, released, distributed and transported according to labelled, regulatory and GxP requirements:
- Review documentation and approve incoming batches of medicinal products, product returns, annual product quality reviews
Skills and Requirements:
- University degree in Engineering, Medical Sciences, Natural Sciences, Pharmaceutics or related discipline (ideally a Master's degree)
- Four years of experience in a Quality role in a regulated industry (Devices or Drugs) with GxP experience, and knowledge of supplier Quality management and Quality auditing.
- Knowledge of GxP, ISO 13485, MDD (as applicable) and local quality regulatory requirements.
- Fluency in German and English both spoken and written is a requirement, French is advantageous
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nick Dietz on +44 203 3193 033 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.