Compliance Manager (f/m/d) 100% Emploi Plein temps
il y a 9 mois - Training - BaselDétails de l'annonce
My main tasks will be...
- Establish procedures to define processes within Quality or support other functions to define and document procedures according to their needs
- Implement global procedures on a local level by assessing gaps, updating or issuing local SOPs
- Responsible for maintaining all documentation effective and updated concerning site relevant processes
- Effective implementation, review and updating of the site quality plan, contamination control strategy and site risk register
- Responsible for the management of site relevant suppliers : introduction, lifecycle, overview and regular review
- Supporting audits to suppliers (virtual /on-site) and follow up with reporting and CAPA plans
- Participate/lead continuous improvement initiatives at the site
- Representing the site to the global quality systems network and supports projects and initiatives on the local level
- liaise with other areas/departments for cross functional topics to be addressed to ensure compliance and harmonisation
- Conduct/support self-inspections and have the overview of the status for the site
- Handle and maintain KPIs with regular reporting and drive improvement initiatives
- Responsible for regulatory surveillance, including compendia as well as pharmaceutical legislation
I bring with me...
- Bachelor, master’s degree in pharmacy, microbiology, biotechnology, life science or related field
- Minimum 5 -8 years of experience in GMP environment , in quality or in operations (manufacturing, QA or in QC)
- Excellent verbal, written and interpersonal communication skills
- Fluent in English (written and spoken)
- Knowledgeable in electronic QMS tools such as Trackwise is a plus
- Good knowledge of MS Office Applications
- Ability to prioritize and manage work to critical project timelines in a fast-paced environment
- Independent, organised and goal-oriented personality
- Solution oriented quality mindset
My reasons for choosing Bacthera...
- Innovative and fast growing start-up company with short decision-making processes
- Flexible working hours (possibility of Home Office)
- Motivated, agile and multinational team
- Very good pension fund and attractive salary
- Fringe benefits (e.g. Lunch card, deduction at different stores, Job ticket for public transport)
- Interesting and diversified tasks
My future working place will be...
Basel / Stücki Business Center
About Us
Bacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.