Principal Quality Systems Specialist
2 semanas atrás
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:
Seasoned professional to be the Hovione Quality Lead for medical devices applied to respiratory drug delivery. This function will play a key role in driving the changes needed to enhance our Quality System for the field of medical devices and combination products. Expected to have a high level of engagement with stakeholders from quality, R&D, business development, regulatory affairs, and sites, as well as with external partners, to drive alignment on quality & regulatory requirements and best practices on medical devices and combination products.
Implements and manages the required guidelines and applicable quality requirements for Hovione, providing LEAN based Quality Systems and Tools, controlled, harmonized, and aligned with the company’s strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites. Maintains active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluates, advises, and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to development, commercialization, and optimization across the full lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits, and other regulatory due diligence. Represents Hovione in professional associations, industry/trade groups.
- Promote the importance of high-quality work levels and the importance of a continuous improvement culture in all core company activities.
- Lead company-wide initiatives, ensuring plan definition and timely execution.
- Manage Corporate Quality key activities related with Medical Devices and Combination Products, such as Procedures, KPI’s, Training, Systems Management (e.g., Documentation management system, CAPA, Change Control, etc.).
- Align, review, and harmonize the applicable quality Systems and Tools within all Sites, according to the demands of the applicable Guidelines and providing proper deployment and training for the Company Sites as appropriate.
- Provide input into the assignment of Team resources for the necessary key area activities.
- Manage Audits/inspections (Internal and External - Suppliers, potential new Customers, Health Authorities) as applicable.
- Demonstrate track record in Quality/Regulatory Systems.
- Solve complex problems with full autonomy.
- Manage risk and uncertainty; anticipate and address roadblocks to prevent deviations to the goals.
- Coach other team members to enhance company effectiveness and promote achievement of high standards within the organization.
- 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 Quality, Regulatory and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, filings, systems, and procedures.
- May qualify as corporate GMP auditor.
- Demonstrated extensive experience in working as a Quality professional on the area of Medical Devices and Combination Products, preferably applied to Respiratory Drug Delivery, including establishing quality procedures and systems.
- Deep specialized knowledge of Quality requirements, cGMP´s, CFR, EU, local or any other as applicable guidelines and ISO Standards for the scope of Medical Devices and Combination Products, preferably applied to Respiratory Drug Delivery.
- University, or equivalent, qualification in Chemistry, Chemical Engineering, Mechanical Engineering, Pharmacy or similar scientific field (mandatory).
- Minimum of 10 years of relevant overall experience in at least 2 operational and support areas (e.g., Quality Systems, Quality Assurance, Quality Control, Manufacturing, R&D, Engineering).
- Deep specialized knowledge of Risk Management applied to Quality Systems.
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Lisboa, Portugal Hovione Tempo inteiroJoin a Market LeaderHovione 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...
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