Expert Validation Specialist
Há 3 dias
Pharmaceutical manufacturers rely on rigorous quality control and compliance measures to ensure the safety and efficacy of their products. As a Commissioning, Qualification, and Validation (CQV) Analyst, you will play a critical role in ensuring that our manufacturing processes and equipment meet regulatory requirements.
The ideal candidate for this position will have a strong understanding of FDA and cGMP regulations, as well as experience with equipment and process validation. You will be responsible for developing and executing commissioning, qualification, and validation protocols for new and existing equipment and processes. This will involve conducting risk assessments and gap analyses to identify areas for improvement in compliance and quality.
You will also perform equipment and process qualifications, including installation, operational, and performance qualifications. In addition, you will review and approve validation documentation, including protocols, reports, and deviations. Your ability to collaborate with cross-functional teams, including engineering, manufacturing, and quality, is essential to ensuring compliance with regulatory requirements and company standards.
Key Responsibilities:
- Develop and execute commissioning, qualification, and validation protocols for new and existing equipment and processes
- Conduct risk assessments and gap analyses to identify areas for improvement in compliance and quality
- Perform equipment and process qualifications, including installation, operational, and performance qualifications
- Review and approve validation documentation, including protocols, reports, and deviations
Requirements:
- Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related field
- Fluent in English; Portuguese is a plus
- Minimum of 3 years experience in commissioning, qualification, and validation in the pharmaceutical industry
- Strong knowledge of FDA and cGMP regulations
- Experience with equipment and process validation, including IQ/OQ/PQ, cleaning validation, and process validation
- Excellent problem-solving and analytical skills
- Strong attention to detail and ability to work independently
- Excellent communication and interpersonal skills
- Ability to prioritize and manage multiple projects simultaneously
Benefits:
- Competitive salary
- Opportunities for professional growth and development
Why Work With Us?
We are a dynamic and innovative company dedicated to delivering high-quality products to our customers. Our team is passionate about making a difference in the lives of patients worldwide. If you share our values and are looking for a challenging and rewarding career opportunity, we encourage you to apply.
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