A rapidly expanding Biotech Manufacturing company based in Cork, is seeking to fill the position of Design, Qualification & Validation (DQV) Manager which is an integral member of their team. This is a senior & permanent position (reporting into the MD) with responsibility for the management of the DQV team. The role comes as the company continues to expand their capabilities and the successful candidate will play a key role in the continued development and strategic direction of the business.
This role is heavily focused on Quality, Validation and Project Management so a strong background and a keen interest in these areas is critical. This individual will be leading the Validation and Qualification on site.
This role is ideal for a manager passionate about driving innovation in the biopharma industry while collaborating across quality, engineering, and production teams.
Core Responsibilities
- Management and execution of the Master Validation Schedule
- Management of product drawing execution and qualification
- Management of Sub-Supplier Component specification & Qualification
- Alignment of Customer User Requirement Specification and Compliance
- Collaborating extensively with the Engineering team in the continued development of both existing and new products introductions.
- Close Cross-Functional Collaboration with the Quality and various site Teams.
- Participating in investigations, change management and complaints as required
- Participating in Audits
Required Skills and Qualifications
- Educational Background: Degree in Process, Biotechnology, or related Engineering field.
- Experience: 8+ years' experience working in a GMP environment across Quality and / or Validation.
- Strong experience managing product lifecycles in a dynamic environment.
- Project management experience (lead out and delivery)
- Analytical and Strategic Thinking: Ability to assess and problem solve
- Communication Skills: Ability to communicate complex concepts clearly and effectively.
- Problem-Solving: Exceptional collaboration and problem-solving abilities.
If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on 021 2300 300.
