Automation QAV Specialist

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.

This person will integrate with the Automation team and will support the qualification and validation from a point of view of Quality to guarantee the GMP standard of the process. They will also be required to:

• Support site personnel in all Automation Qualification and Validation activities
• Plan and/or establish Qualification/Validation requirements ensuring Compliance with relevant guidelines and procedures.
• Assure cGMP compliance before, during and after validation/qualification activities by assuring that all necessary procedures are implemented and are being followed on the site;
• To establish the required qualification activities of new or changed systems and/or facilities within the change control process.
• Approve the URS/AURS/DQ/IQ/OQ/PQ tasks, for all new or changed process/utilities systems in close liaison with the Automation area.
• To perform internal or external audits as required and support customer audits.
• To support all Regulatory Inspections.
• To pro-actively manage Deviations, CAPA’s, Improvement Plans and Change Control activities related to Qualification and Validation of Projects, Equipment, Facilities and Utilities
• Collaborate in the definition of the required Qualification and Validation strategies for different Automation Computerized Systems: Manufacturing equipment, DCS, PLC and other stand-alone software.
• Develop and review / approve specification, testing document templates, as well as internal and standard operating procedures (IOP, SOP).
• Perform validation activities of the Computerized System projects and support teams to ensure compliance with Regulatory and Industry Standards throughout systems’ life cycle.
• Participate as part of multi disciplinary work groups with Quality Assurance, Information Systems, User Areas and other Departments/Sites and contribute to the adequate and timely completion of all validation activities.
• Collaborate in the definition of the required Qualification and Validation strategies for different Computerized Systems: Manufacturing equipment, DCS, PLC and other stand-alone software

• University degree in a Scientific or Engineering discipline.
• Minimum of 3 years’ experience in Equipment Qualification / Validation in the Pharmaceutical Industry;
• Thorough understanding of cGMP and ISPE and GAMP Guidelines.
• Excellent communication skills.
• Ability to discuss technical aspects of Qualification and Validation with clients, suppliers and health authorities.

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.

Notice to Agencies and Search Firms Representatives
Hovione does not accept unsolicited résumes from agencies or search firms for this job posting. Any resumes submitted to Hovione by a third-party agency or search firm without a valid written and signed search agreement will become the sole property of Hovione. No fees will be paid if a candidate is hired for this position as a result of an unsolicited referral. Thank you for your understanding.