What are the responsibilities and job description for the Validation and Compliance Specialist position at BEPC Inc. - Business Excellence Professional Consulting?
Job Description
At BEPC Inc., we are seeking a highly skilled Validation and Compliance Specialist to join our team. As a key member of our operations department, you will be responsible for ensuring the highest level of quality and compliance in our medical device manufacturing process.
About the Role:
- Develop and execute validation protocols to ensure product quality and regulatory compliance.
- Collaborate with cross-functional teams to identify and mitigate potential risks.
- Provide technical engineering support for validations, write and execute IQ, OQ, PQ, TMV, CSV, and SAT validation protocols.
- Ensure that assigned validation activities are carried out in a timely manner and in accordance with current requirements and Good Manufacturing Practices (GMP).
Required Skills and Qualifications:
- Bachelor's degree in Engineering.
- Advanced level of English (reading and writing) with advanced conversational skills in English.
- 7 to 10 years of experience in the manufacturing industry and/or 6 to 9 years of experience in the medical industry.
