Position: CQV Analyst
PharmEng Technology an Efor Group of Companies is seeking a highly motivated and experienced CQV Analyst to join our team. This is a full time, permanent position with opportunities for growth and development within our company. As a CQV Analyst, you will be responsible for ensuring the quality and compliance of our pharmaceutical manufacturing processes and equipment.
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
- Collaborate with cross-functional teams, including engineering, manufacturing, and quality, to ensure compliance with regulatory requirements and company standards
- Troubleshoot equipment and process issues and provide technical support to resolve them
- Participate in audits and inspections, both internal and external, and assist with implementing corrective and preventative actions
- Keep up-to-date with industry regulations and guidelines related to commissioning, qualification, and validation
Qualifications:
- Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related field
- Fluent in English and Portuguese are a must
- 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
We offer a competitive salary, as well as opportunities for professional growth and development. If you are a self-motivated and detail-oriented individual with a passion for ensuring quality and compliance in the pharmaceutical industry, we encourage you to apply for this exciting opportunity. Join our team at PharmEng Technology and make a difference in the lives of patients worldwide.