Sr QA Specialist
From discovery and development through manufacturing and beyond, at HALIX you experience the full journey!
To support us in our steady growth, we are welcoming a Sr QA Specialist!
As Sr QA Specialist you will have responsibility for the maintenance of the quality management system and the validation system. You will also support client projects from a QA perspective and play a role in inspections and client audits.
If you are interested in this versatile and dynamic job, don’t hesitate to apply!
Your tasks
- Act as lead in the maintenance of the HALIX quality system, including e.g. regulatory surveillance, preparation the quality management review, supplier management and lead in quality improvement projects.
- Act as superuser of the eDMS system, including continuous improvement and access management.
- Act as lead in audit and inspection management. A role as lead auditor is an option.
- Act as an internal Quality consultant on applicable regulations and related topics and translate these into daily practice and improvement of the QMS by developing and providing applicable trainings.
- Advise on design of computerized systems validations and process validations including; cleaning validation, sterilization validation, media fills and decontamination processes of clean rooms.
- Act as mentor to (junior) QA specialists.
You have
Preferably a MSc degree in a relevant field, such as pharmacy, chemistry, biology, Biotechnology.
A minimum of 5-7 years of experience in biotechnology and/or pharmaceutical manufacturing and testing, including QA experience.
Broad knowledge of and experience with EU/FDA GMP guidelines and inspections.
Good command of English language, both verbally as in writing.
Experience as superuser of an eDMS or eQMS system is pre.
Experience with validation systems management is a pre.
Experience with Lean management and 6 Sigma methodology is a pre.
Who are we looking for?
We are looking for a senior QA professional who has an accountable, customer focused and cooperative attitude. You have the ambition of contributing to a steadily growing biopharmaceutical company that prioritizes patient well-being.
Our offer
- You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
- A culture that is characterized by entrepreneurial spirit and close and transparent communication. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
- You will be working in our dynamic headquarters in Leiden.
- Being part of a company that is focused on excellence in GMP Manufacturing.
- A competitive salary that matches your responsibilities and experience.
Your application
We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.
Important notice to search firms and recruitment agencies
HALIX does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HALIX Recruitment via recruitment@hal-allergy.com to enquire about a potential recruitment or search agreement with HALIX.
HALIX, Bioscience as a Service
HALIX is a fast growing, biopharmaceutical contract development and manufacturing organization (CDMO) focused on viral vector and recombinant protein products. We support our customers with the development & commercialization of biologics enabling the treatment & prevention of life threatening conditions such as cancer, COVID-19, influenza and other infectious diseases. Our state of the art GMP manufacturing facilities and our experienced and dedicated team of people ensures manufacturing capabilities which meet the highest quality standards, a service oriented way of working and a flexible mindset. If you too would like to become part of an innovative and challenging contract development and manufacturing organization (CDMO), then this is a perfect opportunity!
HALIX is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HALIX is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.
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