CQV Analyst

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

Job Description

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.

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