Senior Supplier QA 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.

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. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.

- Manage Quality Agreements with suppliers: preparation, interaction with supplier, improvements, workflow approval and revision

- Approve procedures, templates, aide-memoires and methodologies to standardize practices related to supplier’s qualification

- Conduct quality due diligences to the suppliers proposed by the Buyers

- Lead supplier audits and manage audit closures with suppliers

- Perform supplier review assessments, for strategic suppliers, to assure compliance with Hovione requirements including verification of supplier questionnaires, declarations and certifications, audits output, quality agreements, quality review of product/ service provided and feedback from other team members

- Approve/Reapprove supplier qualification processes (SMS)

- Manage Customer Direct Buy (CDB) materials

– Ensure, with each Project team QA member, that when materials or services suppliers are selected and qualified by customers the suppliers chosen comply with Hovione requirements

- Disqualify suppliers

- Prepare and coordinate supplier audit plan execution

- Indicate QA auditors to the supplier audit plan

- Issue complaints to suppliers and perform CAPA completions follow-up

- Participate with internal project teams in complex investigations and root cause analysis determination to support supplier complaintsParticipate in client audits and Health Authorities inspections, responding for procedures, methodologies, supplier qualification processes, complaints and all activities approved by SQA

- Participate in the definition of key performance indicators of the area

- Track supplier quality performance and report to management and suppliers

- Analyze and identify trends from quality data and develop proactive measures with supplier in support of continuous improvement

- Perform supplier development activities with suppliers identified, including supplier quality plans, conducting for

- Cause audits, supplier corrective action follow-up and implementing continuous improvement methods and techniques.

- Lead and coach other areas of the organization on supplier qualification methodologies and requirements

- Be a subject matter expert in problem solving methodologies/ root cause analysis and provide training when required

- Master Supplier Quality Assurance processes and tools

- Manage complex projects/ analysis with significant impact on business

- Make quality and timely decisions based on multiple sources of data

- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals

- 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.

- 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)

- University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory)

- Typically requires 5-8 years of relevant experience in Quality Assurance, preferably in a GMP environment (Pharmaceutical Industry preferred)

- Previous experience in supplier auditing, supplier qualification and in writing, evaluation and closing investigations and procedures

- Problem solving and root cause analysis experience in a manufacturing environment

- Advanced knowledge of Quality aspects applied to suppliers, auditing suppliers in the Pharmaceutical Industry, cGMP, ICH guidelines and GDP with the ability to solve complex problems

- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

- Fluency in English is a requirement

- Computer literate with good working knowledge of the MS Office package

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.