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Validation and Qualification Expert for Pharmaceutical Projects
3 weeks ago
About the Role:
We are seeking a highly skilled Qualification and Validation Specialist to join our team at NIRAS Life Science.
The successful candidate will be responsible for ensuring the successful execution of qualification and validation activities across various projects, providing expert advice to clients and colleagues, and driving quality-related activities.
Key Responsibilities:
- Establishing and delivering all qualification and validation activities within projects.
- Acting as an expert and supervisor, providing guidance to colleagues and clients.
- Directly engaging with clients and their Quality Assurance teams, addressing GMP-related queries.
- Facilitating and planning quality-related activities such as User Requirement Specifications (URS), Risk Workshops, Commissioning and Qualification activities (DQ, IQ, OQ, PQ).
- Collaborating with other NIRAS departments to integrate client requirements into project deliverables.
- Engaging in knowledge sharing, sales, and networking activities.
Requirements:
- Solid technical background in engineering, chemical engineering, pharmacy or similar fields.
- Minimum of 5-10 years of operational experience in qualification and validation of equipment, facilities, or processes within the pharmaceutical and life science industries.
- Proven track record of independently delivering qualification documentation according to V/SRV models.
- Ability to work both independently and collaboratively with NIRAS and clients.
- Excellent communication skills, with the ability to translate and present client needs effectively within the project.
- Analytical mindset and adept at navigating dynamic project environments.
- Fluency in spoken and written English.
- A European working permit is required.
