Regulatory Compliance Specialist
Há 4 dias
Hovione is a leading Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.
Job DescriptionWe are seeking a highly skilled Regulatory Compliance Specialist to join our team. The successful candidate will be responsible for implementing and managing guidelines and cGMPs, providing LEAN based Quality Systems and Tools, and promoting a rigorous and continuous improvement culture.
The ideal candidate will have 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.
Skillful in maintaining active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders.
Key Responsibilities- Implement and manage guidelines and cGMPs
- Provide LEAN based Quality Systems and Tools
- Maintain active and efficient communication channels
- Evaluate, advise, and provide services related to regulatory requirements
- Represent Hovione through communications and negotiations with regulatory authorities
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