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Quality Manager (f/m/d) 100%

Bacthera AG
Kantonsstrasse 41 c, 3930 Visp
  • 26.05.2023
  • 100%
  • Fachverantwortung
  • Festanstellung

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.

Create your own future as

Quality Manager (f/m/d) 100%

The QA Manager, as a member of the QA Unit, be involved in the commissioning, qualification and process validation of a new manufacturing facility and in the establishment of the quality management system and process, thus ensuring Quality oversight and compliance with national/international requirements and cGMP standards.

My main tasks will be…
  • involved in all quality related activities for the manufacturing processes
  • Responsible for review and approval of documents such as Standard Operating Procedures, Master Manufacturing Batch Records, Deviations Reports, Change Requests, Qualification/Validation Protocols and Reports etc
  • Ensure all manufacturing related deviations are appropriately investigated and recorded
  • Direct the investigations of customer product complaints and assures the timely completion of the appropriate documentation
  • Responsible to drive CAPA and effectiveness check items to completion and timely closing
  • Perform Batch record reviews for Drug Substance and Drug Product on behalf of the Responsible Person
  • Evaluate product-related changes, assesses relevance to regulatory filings, provides change notifications for endorsement to customers where required and approves the change requests
  • Ensure an efficient GMP compliant life cycle management of all products manufactured
  • Represent QA in project/tech transfer teams for new manufacturing processes.
  • Support and approves project/product specific risk assessments
  • involved and support internal and external audits (incl. inspections by health authorities)
  • Identify emerging QA relevant topics, communicates to the organization and work actively on their development into new or already established Quality and Compliance strategies and/or standards
  • Support GMP training programs to ensure staff is being trained
  • Actively support the Quality culture as a role model
I bring with me…
  • Bachelor degree, Master degree in biotechnology, pharmacy, life science or related field
  • More than 3 years of experience in the GMP regulated pharmaceutical industry, preferably in a quality and compliance role in production and CAPEX projects
  • Strong background GMP regulations
  • Strong team orientation
  • Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
  • Solution-oriented
  • Experienced in representing Quality and Compliance in the operational manufacturing environment
  • General knowledge of manufacturing processes and analytical methods
  • Ability to oversee project execution to identify non-compliance from quality standards
  • Ability to prioritize and manage work to critical project timelines in a fast-paced environment
  • A good operational level of both English; German is an asset
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