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:
1. Assigned projects that may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints and Customer requirements;
2. Ensure inspection readiness in work completed and act in an advisory capacity for all internal and external site audits, taking a lead on the most complex situations;
3. Periodic follow-up of ongoing deviations and change controls to assure timely closure of deviations;
4. Review regulatory documentation and co-ordination of site documentation to support regulatory requirements;
5. Solve challenges related to compliance problems by providing collaborative and timely support to all areas and departments, escalating as required;
6. Develop and accumulate strong Quality Assurance expertise, promote the importance of continuous improvement culture and act as a catalyst for change and improvement in performance/quality;
7. Rigorously, accurately, efficiently, and professionally manage all analytical activities for assigned projects and products, ensuring compliance with cGMP, quality operational standards, procedures, and legal regulations, maintaining the site in an "audit ready" state, and preparing, reviewing, and approving auxiliary documentation, protocols, quality-related reports, product specifications, and process validation protocols and reports as needed.
8. Coordinate and assist analysis and any other investigation, example given (analytical investigation on HPLC, GC, others) including customer complaints that may arise and manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals;
9. Make quality and timely decisions based on multiple sources of data;
10. 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
We are looking to recruit a Candidate:
11. University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar Chemistry, Biochemistry or Health Sciences field;
12. Experience in QA and/or QC laboratory environment, preferably under pharmaceutical cGMP;
13. Fluency in English is a requirement;
14. Must have the Knowledge, Experience and Skills to conduct and plan/organize their tasks in accordance with the rules and procedures set down;
15. Knowledge of GMP and ICH practices, analytical theory, and techniques with the ability to solve complex problems;
16. Knowledge of EU/US quality related pharmaceutical regulations;
17. Experience in conducting quality-based investigations and root cause analysis;
18. Experience of HSE rules and regulations (mandatory).