What are the responsibilities and job description for the Qualification & Validation Specialist position at Hovione?
Join a Market Leader
Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.
Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.
Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.
You will be responsible to:
Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.
- Assure cGMP compliance before, during and after validation/qualification activities of systems/equipment and manufacturing processes by assuring that all necessary procedures are implemented and are being followed
- Assure that systems/processes/methods are qualified/validated according to their intended use and product requirements
- Promote the importance of high-quality levels and the importance of a continuous improvement culture in core company activities
- Support Quality and Operational areas, promoting a continuous improvement culture and compliant with the applicable regulations and approved procedures
- Participate in the alignment and harmonization of the Qualification and Validation procedures within all Hovione sites, as requested by Corporate function
- Contribute for the alignment of Qualification and Validation methodologies among Digital (Automation/IT), Engineering, Maintenance, Production Areas and Quality Control, when applicable, to benefit systems compliance
- Participate in Conceptual, Basic and Detailed Design Review for Projects of each Hovione Site, and major Projects at any Site for Corporate function, in order to assure GMP compliance with applicable Guidelines, Corporate Procedures and any specific Site requirements
- Provide input to Plan and/or establish Qualification and Validation requirements for each project within the Team
- Establishes the required qualification activities of new or changed systems and/or facilities within the change control process
- Prepare VMPs for Projects of each Site, collaborate in the VMP for major Projects and support Project’s execution at each site, for Corporate functions
- Approve (pre and pro execution) Qualification and Validation protocols as well as Final VMP Report (for major Projects) and other systems’ related documentation such as Periodic
- Review Reports, at Site level Participate in the management of Quality Systems key activities
- Prepare/review Quality Systems methodologies related to the area objectives and provide training for the sites
- Propose qualification/validation related procedures and documents to be followed
- Participates or support internal or external/customer audits and health authority inspections
- Control/close/approve deviations, CAPA, improvement plans, and change control related to Qualification and Validation of Systems under her / his responsibility
- Propose improvements to the area as appropriate and solve problems
- Make quality, safely and timely decisions within the Qualification and Validation tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- 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.
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
We are looking to recruit a Candidate:
- University, or equivalent, qualification in Chemistry, Chemical Engineering, Mechanical Engineering or similar scientific field (mandatory)
- 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 their tasks in accordance with the rules and procedures set down.
- Fluency in English is a requirement
- Computer literate with good working knowledge of the MS Office package
Hovione is a proud Equal Opportunity Employer
Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.
