Regulatory Compliance Auditor
1 week ago
About Us
PSC Biotech provides essential services to the life sciences industry, ensuring compliance with regulatory requirements. Our goal is to help clients achieve success through our expertise and global presence.
Job Description
We are hiring a QA Auditor to support the transition of a new CMO facility. The successful candidate will be responsible for conducting SOP audits, gap analyses, and staff training.
Main Tasks:
- Conduct thorough GAP analysis and auditing of standard operating procedures.
- Develop and implement quality recommendations for GxP processes and environmental monitoring procedures.
- Design and deliver high-level GMP training programs for staff members.
- Establish and maintain GMP processes that meet industry regulations and compliance standards.
- Provide technical guidance and support for program changes and execution.
Qualifications:
- Bachelor's degree in a relevant scientific field.
- Minimum 5 years of quality assurance experience in the pharmaceutical and/or biotech industry.
- Strong understanding of cGxP regulations, EU regulations, and industry compliance.
- Experience in quality auditing and GAP analysis.
- Proven track record of reviewing and editing standard operating procedures.
- Excellent communication and training skills.
- Analytical and problem-solving abilities.
Salary: Estimated $45 - $60 per hour.
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