Quality Assurance Specialist
2 semanas atrás
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. Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project.
2. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle.
3. Provides global supplier qualification services in support of new product introduction and existing products.
4. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.
5. Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and/or products in accordance with applicable cGMP, quality operational standards/procedures and legal regulations, ensuring the site is always "audit ready".
6. Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities.
7. Act as a catalyst for change and improvement in performance/quality.
8. 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.
9. Prepare for and support internal and external site audits and inspections, conducting regular reviews and periodically following-up action plans as necessary.
10. Ensure inspection readiness in work completed and act in an advisory capacity for all internal and external site audits.
11. Periodic follow-up of ongoing deviations and PdAs to assure timely closure of deviations and approval of PdAs, as appropriate.
12. Close open deviations and propose CAPAs based on the outcome of periodic follow-ups.
13. Prepare SOPs, department IOPs, quality related reports, revision of executed batch documentation and change control documents (PdAs) as required and appropriate.
14. Ensure the effective and proactive flow of information between stakeholders, representing the team as appropriate.
15. Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner.
16. Make quality and timely decisions within the Quality Assurance tasks under her/his responsibility.
17. Gather relevant data to inform the decision makers regarding complex issues.
18. 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).
19. Undertake any additional tasks commensurate with the role as and when required.
We are looking to recruit a Candidate:
1. University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory).
2. Typically requires 3-5 years of relevant experience in a QA GMP environment within the Pharmaceutical Industry (highly desirable).
3. Experience of working in a GMP operational environment (mandatory).
4. Training and experience of GMP standards (mandatory).
5. Strong understanding and knowledge of GMP practices.
6. Fluency in English is a requirement.
7. Computer literate with good working knowledge of the MS Office package.
8. Strong 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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