Market Leader Position
Hovione is a contract development and manufacturing company dedicated to helping pharmaceutical customers bring new and off-patent drugs to market.
Our team members are our main asset for continued success, with 1950 people from 36 nationalities across Asia, Europe, and North America.
As a Qualification & Validation Specialist, you will ensure facilities, equipment, and systems meet quality standards.
Main Responsibilities:
* Ensure compliance before, during, and after qualification/validation activities.
* Validate systems, equipment, and processes according to intended use and product requirements.
* Support continuous improvement and promote a quality-driven culture.
* Align qualification and validation procedures across sites.
* Collaborate with engineering, maintenance, production, and quality control teams to ensure system compliance.
* Participate in project design reviews to ensure compliance.
* Develop and approve validation protocols, VMPs, and related documentation.
* Support audits and inspections, and manage deviations, CAPAs, and change controls.
* Provide training and contribute to the development of quality system methodologies.
* Ensure safe work practices and compliance with guidelines.
Education & Experience:
* A degree in Chemistry, Chemical Engineering, Mechanical Engineering, or a related scientific field (mandatory).
* 3–5 years of experience in Qualification & Validation, preferably in a regulated environment.
Technical Skills:
* Strong knowledge of regulatory guidelines, risk assessment methodologies.
* Experience with process and HVAC systems is beneficial.
* Fluent English; proficient in MS Office.
Soft Skills:
* Strong problem-solving and decision-making abilities.
* Ability to work independently and collaboratively.
* Excellent communication and documentation skills.
Why Join Us?
* Be part of a mission-driven organization that values quality, innovation, and collaboration.
* Work in a dynamic environment with opportunities for growth.
* Contribute to global projects and initiatives.