Quality Assurance and Validation Specialist
2 semanas atrás
Hovione is a leading contract development and manufacturing company dedicated to helping pharmaceutical customers bring new and off-patent drugs to market.
We are looking for a Quality Assurance and Validation Specialist to join our team in this exciting role.
Key Responsibilities:
- Define and implement procedures and processes to ensure compliance with quality standards, documenting evidence that facilities, equipment, and systems can perform effectively and reproducibly.
- Collaborate with colleagues to support the design of test strategies and methodologies for qualification and validation application, developing and deploying best practices.
- Assure cGMP compliance in activities related to Qualification and Validation of systems/equipment, utilities, and facilities throughout their lifecycle.
- Coach/train Sites' Quality and Operational areas, promoting a culture of continuous improvement standards to guarantee the fulfillment of latest applicable regulations.
Requirements:
- University or equivalent qualification in Chemistry, Chemical Engineering, Mechanical Engineering, or similar scientific field (mandatory).
- Typically requires 5-8 years of relevant experience in Quality and Qualification and Validation in an industry environment.
- Advanced knowledge of Quality, Engineering, cGMP, ICH, and ISO guidelines, Risk Assessment applied to Qualification and Validation, and LEAN 6-Sigma with the ability to solve complex problems.
- Fluency in English is a requirement.
- Computer literate with good working knowledge of the MS Office package.
What We Offer:
- A competitive salary of $120,000 - $150,000 per annum, depending on experience.
- An opportunity to work with a leading contract development and manufacturing company.
- A dynamic and inclusive work environment where differences are valued and everyone is treated with fairness and respect.
- Ongoing training and professional development opportunities.
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