Quality Systems Associate
1 semana 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:
Implements and manages the required guidelines and cGMPs 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 product development, commercialization and optimization across the full product lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits and other regulatory due diligence. Represents Hovione through communications and negotiations with regulatory authorities, preparing, submitting and managing all matters related to regulatory submissions and licensing for Hovione and customer products; and within professional associations, industry/trade groups.
- Use as standard for own work high-quality levels and a mindset of continuous improvement
- Advise Team Members on Quality or Regulatory systems and Tools and provide support in the what are the best courses of action
- Provide support in the preparation of new procedures and/or policies according to the requirements applicable to the company business and strategy and propose changes to the existing procedures as applicable
- Provide support in the preparation of Quality and/or Regulatory Systems and Tools related documentation and training
- Provide support to audits/inspections (Internal and of Health Authorities) Participate in other Corporate key activities, such as Corporate Quality or Regulatory KPI’s, Corporate Quality or Regulatory Training, Quality and/or Regulatory Systems Management (e.g., Documentation Management System, CAPA, Change Control, analytical computerized systems fillings, customer support, etc.)
- 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.
- Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Execute professional activities in compliance with Quality, Regulatory 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, Pharmacy or similar scientific field (mandatory)
- Requires educational and/or training experience in operational areas (e.g., Quality Control, Quality Assurance, Manufacturing, R&D, Engineering) preferably within the Pharmaceutical Industry
- Knowledge of Quality requirements, cGMP´s, ICH, CFR, EU, local or any other as applicable guidelines and ISO Standards as applicable
- 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.
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