Quality Coordinator

Hobson Prior are looking for a Quality Coordinator to join a growing biopharmaceutical company in Switzerland who focus on discovering, developing and bringing more, pioneering medicines to patients. You will join them on a contract basis in Basel.

Job Responsibilities:

• Responsible for the management of QA related Documents in Veeva, e.g. Validation documentation, QbD documents, MBR, EBR etc.
• Management Veeva, Reports, Binders, as well as KPI tracking and improvement activities.
• Performs assigned tasks in accordance with applicable QS Documents (e.g. SOPs, WIS etc.).
• Approval of SAP Master Data, release transactions, extension of shelf life, etc.
• Support of Supplier Qualification activities, like review of questionnaires, KPI monitoring etc.
• Support and advise the project team regarding pharmaceutical development related to regulatory strategy for submission.
• Assist GMP/GDP onsite audits at Contract Manufacturing Organizations (CMOs) on demand.
• Support for small projects, e.g. 2nd source suppliers, or Phase I project.
• Provide quality monitoring and advise to others functions according to employee's expertise.
• Preparation and monitoring of Deviations, CAPA, OOS/OOE.
• TQA preparation and monitoring.
• Write, review, and/or approve internal SOP's and other, according to employee's expertise.
• Coordination of complaints.
• Managing archiving of paper-based documentation for the QA Department.

Key Skills:

• Ability to independently perform assigned tasks within given timelines.
• Timely communication of any anticipated delays to meet given timelines.
• Fluent in English and at least basic knowledge of an additional language, German, French or Chinese is beneficial.

Requirements:

• University-degree (Master preferred) or equivalent education in the field of chemistry, biochemistry, biology, pharmacy, or chemical engineering.
• Minimum of 1 year of experience in quality assurance in GMP regulated environment.
• Alternatively experience in other related fields, e.g. analytical / synthetical laboratories or similar operational positions in the pharmaceutical industry.
• Knowledge and understanding of drug substance development, manufacturing process, quality control, packaging and distribution.
• Knowledge of (c)GMP/GDP's.
• Ability to pro-actively notice, report, and work on quality gaps and quality improvements.
• Advanced SAP knowledge is a plus.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.