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 for:
Efficiently, accurately and reliably ensure that project and/or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured;
Manage and participate in Quality Product key activities for the assigned product/projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports;
Prepare for and support internal and external site audits and inspections, conducting regular reviews and periodically following-up action plans as necessary;
Ensure inspection readiness in work completed and act in an advisory capacity for all internal and external site audits;
Periodic follow-up of ongoing deviations and Change Controls (PdAs) to assure timely closure of deviations and approval of PdAs, as appropriate;
Prepares SOPs, department IOPs, quality related reports and change control documents (PdAs) as required and appropriate;
Review process master documentation, revision of executed batch documentation and product specifications as required and appropriate;
Review regulatory documentation and co-ordination of site documentation to support regulatory requirements;
Authorize the usage of production equipment/utilities when qualification required.
We are looking to recruit a Candidate:
University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory);
Requires educational/training experience in Chemical environment (desirable);
Fluency in English is a requirement;
Computer literate with good working knowledge of the MS Office package;
Good documentation skills and attention to detail.
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.
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