For our client, a leading international pharmaceutical company in Basel, CH, we are looking or a motivated personality in the function of
Quality Manager (API and Pharma strategic raw materials)
Raw material supplier evaluation/qualification & audits:
- Responsible for proposing and controlling the implementation of appropriate corrective and preventive actions at suppliers as resulting from the audit observations.
- He/she assesses & approves from the quality perspective any new source (e.g. in the frame of New Product Developments) of APIs and Raw Materials, identifying potential challenges to be faced and working with the suppliers to overcome challenges within appropriate time in order to enable the new product implementation on the market.
- Supports local organizations and production sites for the proper supplier qualification by collecting and evaluating supplier's documentation.
- Responsible to coordinate audit needs with procurement, local organizations, project teams and with the internal compliance group
- Supports the creation and maintenance of QA agreements between with API & Raw Material suppliers or with customers.
- Manages quality related topics for example but not limited to risk assessments, deviation investigation and others for the suppliers which he/she is assigned to.
Divisional QA manager:
- Assures coordination with suppliers and sites failure investigations and CAPAs in case of deviations/complaints/Out of Specification if materials are impacted or if this impacts several production sites.
- Supports company´s sites with regard to any qualitative topics related to supplier qualification and evaluation, Risk assessments.
Project management / definition of quality standards / review & implementation of new legal requirements:
- Participates or leads project teams for identified issues with QA and regulatory impact
- Evaluates new guidelines/ upcoming pharmaceutical regulations, evaluate impact and assure proper implementation in daily business.
- Change management: QA representative of the company API&raw material evaluation team Reviews, evaluates changes received from suppliers, performs QA approval within the Change Management System Synaps, supports and controls change implementation
Your qualifications and experience:
- Degree Chemist or Chemical Engineer
- Years of experience in a similar environment At least 5 years working experience in regulated environment, with at least 2 in Quality management.
- Working experience in laboratories and in analytical methods development and/or experience in development of APIs and drug products. Advanced know how on cGMP, ICH, IPEC and ISO as well as other relevant national and international quality assurance regulations for APIs, excipients, food and cosmetic ingredients.
- Experience with Microsoft Office, Trackwise, SAP.
- Fluent English
- Soft skills Team work, excellent communication skills, process oriented, capable to manage cross-functional teams.
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Stefanie Bucheli ()