Sr TechOps Quality Support Engineer
To support the further grow of the HALIX organization, we are looking for a Senior TechOps Quality Support Engineer.
The Senior TechOps Quality Support Engineer (Sr. TQS Engineer) is responsible for ensuring the highest quality standards in our HALIX Technical Operations (TechOps), by taking ownership of the TechOps quality system. In doing so, you will ensure the correct and timely handling of batch record review and quality records and take initiatives to prevent and limit backlogs.
This role includes overseeing quality assurance processes, making proposals in the context of increasing operational efficiency within the TechOps team.
The Sr. TQS Engineer will work closely with key stakeholders of QA and Project Management and will report to the Production Manager.
Your tasks
Deliverables:
- Ensuring the handling of all quality records in a timely manner, by supporting and coaching the TechOps departments (Production, Supply Chain and EVM&FM) on the right content and due dates
- Contribute to the value chain by supporting the release process for batch record review
- Creating KPI’s and dashboards and managing due dates for quality records and relevant documents, including reports for (senior) management
- Develop and document a comprehensive quality system for TechOps.
- Identify and implement continuous improvement initiatives to improve operational efficiency and quality
- Design and execute training programs for technology operations team, ensuring a consistent understanding of quality standards (including problem solving and root cause investigation tools and methodologies)
- Facilitate cross-functional team meetings, documenting and tracking actions
Responsibilities:
- Develop, implement, and maintain quality assurance protocols and metrics for TechOps.
- Support and coach TechOps personnel by providing guidance and support to ensure compliance with quality standards.
- Identify areas for continuous quality improvement and work collaboratively with cross-functional teams to implement effective solutions.
- Monitor and analyse key performance indicators (KPIs) to assess the effectiveness of operations and quality initiatives.
- Prepare and present regular reports on quality metrics and performance to (senior) management.
- Design and deliver training programs to enhance the skills of the TechOps team and other operational staff.
- Ensure adherence to industry standards, regulatory requirements, and internal policies related to quality management.
You have
- BSc or MSc degree in a relevant field (e.g., engineering, biotechnology), or proven equivalent by work experience.
- At least 5 years of experience in working in a comparable role (quality assurance, operations/manufacturing or continuous improvement) in a biopharmaceutical company
- Excellent analytical and problem-solving abilities and proficiency in quality management systems, tools and methodologies (eg., LSS)
- Strong communication and interpersonal skills
- Good command of the English and language, both verbally as in writing. Dutch is advantageous
- Ability to work collaboratively across departments and drive change
Who are we looking for?
We are looking for a candidate who has a quality oriented and customer focused mindset.
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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