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Computer System Quality Manager
Il y a 7 mois
COMPUTER SYSTEM QUALITY MANAGER
- Biotech- Ghent & remoteWHAT IS OFFERED
We offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success.
We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending on your seniority, a car may be provided.
We provide personalized training to let you grow in the area of
- What you like to do
- What you are good at
- Where and how you want to have an impact
ABOUT THE COMPANY
We offer the opportunity to:
- Seize the driver’s seat in the exhilarating world of therapeutic antibody development.
- Join a work environment in a human‐sized, dynamic and rapidly growing biotech company
- Contribute to the build out of a global manufacturing network for innovative pharmaceutical product
- Revel in a competitive salary package adorned with an array of enticing benefits.
- A flexible work environment with the possibility to work hybrid
Our partner is looking for a computer systems quality (CSQ) manager to expand their QA team. In this role you will be responsible for:
- Developing and executing CS Quality strategies, providing vital support to the QA team.
- Managing the CS Quality audit program, ensuring adherence to stringent standards.
- Leading and supporting GxP-determination and validation activities for worldwide CS systems.
- Collaborating with cross-functional partners to develop, review and manage designated validation deliverables (including System Risk Assessments and Validation/Qualification Plans).
- Expertly evaluating, testing and validating software and SOPs
- Taking the lead or collaborating on Quality projects to enhance and upgrade CS systems and processes.
- Offering invaluable guidance as a Subject Matter Expert, supporting both local and global CS QA efforts.
- Crafting and implementing QA problem reporting processes and systems, ensuring timely and effective solutions.
- Analyzing service or performance deficiencies and providing recommendations for enhancements.
- Ensuring all computerized systems meet applicable GxP regulatory and company requirements throughout their lifecycle.
- Spearheading the design and implementation of defect reduction programs, driving continuous improvement.
REQUIRED COMPETENCES & SKILLS
- You have a master or doctorate (Ph.D.) degree in Sciences, bio-informatica or Biological Engineering.
- Proven experience in computer systems validation and time spent in quality assurance/compliance function
- Expert knowledge in Software Development Life Cycle (SDLC), IT Quality Management Systems, Computer Systems Validation, internal and external audits
- Expert knowledge of CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11.)
- Experience with the implementation and maintenance of electronic Quality and Document Management system(s)
- Knowledge of relevant scientific discipline or equivalent through education and experience
- Knowledge of Gxp regulatory requirements is preferres (i.e. GCP, GLP, GMP)
- Team player and good communication skills.
- Quality-minded individual who is accurate in execution and reporting
- Flexible attitude, capable of picking up the tasks that require attention
- Proficiency with MS Office & SharePoint
- Fluent in English - working language
Are you ready to be captivated by innovation, to shape the future of medicine and to work alongside a dynamic team dedicated to making a difference? Join us now and let’s make waves in the realm of biopharmaceutical brilliance
