Senior Quality Assurance Specialist

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:
Guarantee cGMP compliance in all activities and systems related to Projects and Products execution.
Assure that working practices are streamlined and aligned with the actual needs of each project.
Implement policies, procedures and methods to evaluate and continuously improve the quality of products and operations throughout the product lifecycle.
Provide global supplier qualification services in support of new product introduction and existing products.
Collaborate with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.
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."
Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities.
Act as a catalyst for change and improvement in performance/quality.
Provide an example of professionalism and lead the induction and training of new colleagues within the area.
Manage and participate in Quality Product key activities for the assigned product/projects, including preparation, review and approval of auxiliary documentation, protocols and quality-related reports.
Authorize the release for sale of finished products (applicable to site without QP).
Prepare for and support internal and external site audits and inspections.
Ensure inspection readiness in work completed and act in an advisory capacity for all internal and external site audits.
Close open deviations and propose CAPAs based on the outcome of periodic follow-ups.
Prepare SOPs, department IOPs, quality-related reports, revision of executed batch documentation and change control documents (PdAs) as required.
Review regulatory documentation and coordinate site documentation to support regulatory requirements.
Ensure the effective and proactive flow of information between stakeholders.
Promote compliance on Health, Safety and Environment in the area and activities for which you are responsible.
Maintain a regular presence on the manufacturing floor, providing on-the-job support.
Lead the development and sign-off of training materials.
Manage complex projects/analysis with significant impact on business.
Execute professional activities in compliance with GMP and HSE guidelines.
Undertake any additional tasks commensurate with the role as required.
We are looking to recruit a Candidate:
University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory).
Typically requires 5-8 years of relevant experience within a QA GMP environment within the Pharmaceutical Industry (mandatory).
Experience of working in a GMP operational environment (mandatory).
Training and experience of GMP standards (mandatory).
Experience of working with Regulatory Affairs and a well-rounded knowledge of the function (mandatory).
Fluency in English is a requirement.
Computer literate with good working knowledge of the MS Office package.
Advanced documentation skills and attention to detail.
Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
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.
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