New position for a Quality Assurance Specialist with experience in Tech Transfer and UpStream Processing within a large international pharmaceutical concern!
Introduction:
Our client is embarking on Project Pollux, the establishment of a new Lentiviral Vector (LVV) production facility as part of Janssen Biologics B.V. The project aims to become a key supplier for commercial LVV, supporting the global Janssen BCMA CAR-T program for multiple myeloma. As a Senior QA Associate, you will play a crucial role in providing QA oversight over the Qualification of the facility, utilities, automation, and production equipment. This is an exciting opportunity to make a significant impact on the health of patients worldwide. If you possess strong communication skills, a risk-based mindset, and great attention to detail, please keep reading.
Job Description:
s a Senior QA Associate for Project Pollux, you will be a primary Quality contact in the project, ensuring compliance with regulatory requirements, health and safety guidelines, and cGMP standards. Your responsibilities will include setting GMP standards and guidelines for commissioning and qualification, ensuring Data Integrity requirements and CSV compliance. You will review and approve GMP documentation from a QA perspective, such as qualification protocols and reports, automation documentation, and electronic Master Batch Records/MES. Additionally, you will translate C&Q learnings into proper controls in SOPs and Work Instructions for operations, maintenance, or other processes. Your role will involve using Risk Management tools and advocating for their implementation within the project team. Furthermore, you will review and approve non-conformance investigations, ensuring timely corrective actions. As a Senior QA Specialist, you will actively align requirements and expectations with external (Quality) contacts in the LVV/CAR-T supply chain.
Responsibilities:
- Be the primary Quality contact in the Pollux project, ensuring compliance with regulatory requirements and cGMP standards
- Set GMP standards and guidelines for commissioning and qualification, in line with regulations and leveraging best practices
- Review and approve GMP documentation from a QA perspective, including qualification protocols and reports, automation documentation, and electronic Master Batch Records/MES
- Translate C&Q learnings into proper controls in SOPs and Work Instructions for operations, maintenance, or other processes
- Utilize Risk Management tools and advocate for their use within the project team
- Review and approve non-conformance investigations, ensuring timely implementation of corrective actions
- Drive the introduction of emerging technological/digital solutions in Quality
- Actively align requirements and expectations with external (Quality) contacts in the LVV/CAR-T supply chain
- Work closely with colleagues at the Site and globally, sharing Best Practices and exceeding Customer needs
Requirements:
- Proven experience in a Quality role in the biotechnical or pharmaceutical industry, with a minimum of 4-8 years in a GMP regulated environment
- Bachelor's or higher degree in Engineering or another technical background is preferred; other relevant educations such as Biochemistry or Pharmaceuticals will be considered
- Excellent understanding and application of Global Regulatory (cGMP/ICH/FDA/EMA) guidelines
- Strong problem-solving skills in a complex environment, balancing business needs, regulatory requirements, and cost efficiency for all Quality decisions
- Ability to drive teamwork in a fast-paced environment and connect easily at all levels in the organization
- Empowered professional who drives a Quality Mindset and can make well-motivated pragmatic decisions independently
- Working knowledge of Eudralex Annex 1 is advantageous
- Proficiency in English both in writing and speaking
- Limited travel required for the job, with occasional on-site work demands
Benefits:
- Contract; ~1 year through Oxford
- Salary; €3750 - €7500 based on a fulltime, 40 hour work week. Height of the salary depends on your experience and background
- Opportunity to work on a project that impacts the health of patients worldwide
- Chance to work with a dynamic and diverse team, driving Quality decisions and embracing innovation
- Holidays; 25
- Working hours; full-time, 32 hours possible; remote work is possible for this position (2-3 days varying with the amount of work that needs to be done)
Vacancy number; 23273
