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Regulatory Compliance Specialist
2 months ago
Job Summary:
Cpl Healthcare is seeking a highly skilled Quality Assurance Specialist to support our client, a global pharmaceutical company, in their quality and validation efforts. The ideal candidate will have experience in writing reports, executing lab studies, and providing subject matter expertise in Microbiological Assays.
Key Responsibilities:
- Develop and implement quality assurance protocols and procedures
- Conduct method validations and lab studies to ensure compliance with regulatory requirements
- Provide subject matter expertise in Microbiological Assays and support QC lab investigations
- Lead standard method transfer, validation, and verification projects
- Collaborate with cross-functional teams to ensure quality and compliance
- Analyze data and identify trends to inform quality improvement initiatives
- Develop and maintain quality documentation and records
- Stay up-to-date with regulatory requirements and industry best practices
Requirements:
- Experience in quality assurance and validation in a pharmaceutical or biotechnology setting
- Strong knowledge of regulatory requirements and industry standards
- Excellent communication and analytical skills
- Ability to work independently and as part of a team
- Strong attention to detail and organizational skills