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Quality Systems Specialist
2 semanas atrás
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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:- Implement and manage 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.
- Maintain active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders.
- Evaluate, advise and provide 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.
- Represent 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.
- Promote high-quality work within the team and a mindset of continuous improvement.
- Advise Team Members when unconformities with Quality or Regulatory Systems and Tools have been identified and promote corrective actions.
- Propose new procedures and/or policies according to the requirements applicable to the company business and strategy and review existing procedures.
- Prepare Quality and/or Regulatory Systems and Tools related documentation and training.
- Participate in Audits/inspections (Internal and of Health Authorities).
- Perform other Corporate key activities, such as delivering 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, corporate analytical electronic systems, filings, customer support etc.
- Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner.
- Propose improvements to the area as appropriate and solve problems.
- Lead initiatives within group or department, ensuring plan definition and timely execution.
- Make quality and timely decisions within the Quality and/or Regulatory Systems’ tasks under her/his responsibility.
- Gather relevant data to inform the decision makers regarding complex issues.
- 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 applicable 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). May qualify as internal GMP auditor.
- University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmacy or similar scientific field (mandatory).
- Typically requires 3-5 years of relevant experience in operational areas (e.g., Quality Control, Quality Assurance, Manufacturing, R&D, Engineering), preferably within the Pharmaceutical Industry.
- Strong understanding and knowledge of Quality and/or Regulatory requirements, cGMPs, ICH, CFR, EU, local or any other applicable guidelines and ISO Standards 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.
