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 :
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 suppliersPrepare and coordinate supplier audit plan executionIndicate QA auditors to the supplier audit planIssue complaints to suppliers and perform CAPA completions follow-upParticipate 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 SQAParticipate in the definition of key performance indicators of the areaTrack supplier quality performance and report to management and suppliersAnalyze and identify trends from quality data and develop proactive measures with supplier in support of continuous improvementPerform supplier development activities with suppliers identified, including supplier quality plans, conducting forCause 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 requirementsBe a subject matter expert in problem solving methodologies / root cause analysis and provide training when requiredMaster Supplier Quality Assurance processes and toolsManage complex projects / analysis with significant impact on businessMake quality and timely decisions based on multiple sources of dataManage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goalsCarry 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)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 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 proceduresProblem solving and root cause analysis experience in a manufacturing environmentAdvanced knowledge of Quality aspects applied to suppliers, auditing suppliers in the Pharmaceutical Industry, cGMP, ICH guidelines and GDP with the ability to solve complex problemsMust have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.Fluency in English is a requirementComputer literate with good working knowledge of the MS Office package