Regulatory Compliance Expert
2 weeks ago
About PharmEng Technology
Job Summary: We are seeking a highly skilled Regulatory Compliance Expert to join our team as a Quality Assurance Consultant. In this role, you will be responsible for ensuring the implementation, maintenance, and oversight of the Quality Management System (QMS) in local affiliates.
Key Responsibilities:
- Implementing and maintaining a robust Quality Management System (QMS)
- Ensuring compliance with regulatory requirements and quality standards
- Managing quality risk and developing effective strategies to mitigate risks
- Leading complaint resolution processes and managing deviations
- Collaborating with cross-functional teams to implement change control procedures
- Coordinating product quality reviews (PQR)
- Delivering training programs to local staff
- Ensuring GDP requirements are met for local warehousing and distribution
- Monitoring GxP suppliers and their compliance status
Requirements
- Bachelor's degree in Quality Management, Life Sciences, or a related field
- Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or healthcare industry
- Strong knowledge of GxP regulations and quality standards
- Excellent analytical, problem-solving, and communication skills
- Ability to work independently and collaboratively in a team environment
- Proficiency in using Quality Management Systems and Learning Management Systems (LMS)
About Us
PharmEng Technology is a leading provider of pharmaceutical solutions. Our team is passionate about delivering high-quality products and services to our clients.
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