Hovione is a leading Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.
Job Description
We are seeking a highly skilled Qualification and Validation (Q&V) Specialist to join our team. As a Q&V Specialist, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes and systems.
Key Responsibilities
1. Define and implement procedures and processes to ensure that Hovione facilities, equipment, and supporting systems are fit for purpose and comply with applicable quality standards.
2. Assure cGMP compliance before, during, and after validation/qualification activities of systems/equipment and manufacturing processes.
3. Ensure that systems/processes/methods are qualified/validated according to their intended use and product requirements.
4. Promote high-quality levels and a continuous improvement culture in core company activities.
5. Support Quality and Operational areas, promoting compliance with applicable regulations and approved procedures.
6. Participate in the alignment and harmonization of Qualification and Validation procedures within all Hovione sites.
7. Contribute to the alignment of Qualification and Validation methodologies among Digital, Engineering, Maintenance, Production Areas, and Quality Control.
8. Participate in Conceptual, Basic, and Detailed Design Review for Projects at each Hovione Site.
9. Provide input to Plan and/or establish Qualification and Validation requirements for each project.
10. Establish qualification activities of new or changed systems and/or facilities within the change control process.
11. Prepare VMPs for Projects at each Site and collaborate on major Projects.
12. Approve Qualification and Validation protocols and Final VMP Reports.
13. Participate in the management of Quality Systems key activities.
14. Prepare/review Quality Systems methodologies related to area objectives and provide training for sites.
15. Propose qualification/validation-related procedures and documents.
16. Participate or support internal or external/customer audits and health authority inspections.
17. Control/close/approve deviations, CAPA, improvement plans, and change control related to Qualification and Validation of Systems.
18. Propose improvements to the area as appropriate and solve problems.
19. Make quality, safety, and timely decisions within Qualification and Validation tasks.
20. Gather relevant data to inform decision makers regarding complex issues.
21. Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations, and codes of practice.
Requirements
* University degree or equivalent in Chemistry, Chemical Engineering, Mechanical Engineering, or similar scientific field.
* Typically requires 3-5 years of relevant experience in Quality and Qualification and Validation, preferably in an industry environment.
* Strong understanding and knowledge of Quality, Engineering (applied to Processes and HVAC systems), cGMP, ICH, and ISO guidelines, Risk Assessment applied to Qualification and Validation.
* Must have the Knowledge, Experience, and Skills to conduct tasks in accordance with rules and procedures set down.
* Fluency in English is a requirement.
* Computer literate with good working knowledge of the MS Office package.
About Us
Hovione is a proud Equal Opportunity Employer committed to creating an inclusive work environment where everyone feels valued, respected, and supported. We believe in diversity and inclusion and strive to create a workplace where everyone can thrive, regardless of age, gender, religion, disability, sexual orientation, or ethnicity.