Descripción de la oferta
PharmEng Technology is seeking a highly motivated and experienced CQV Consultant to join our team on a full-time, permanent basis. As a global leader in pharmaceutical engineering and consulting services, we are dedicated to providing our clients with the highest quality solutions to ensure the safety, efficacy, and compliance of their products.
Key Responsibilities
Develop and execute commissioning, qualification, and validation protocols for pharmaceutical manufacturing equipment, facilities, and utilities.
Conduct risk assessments and gap analyses to identify potential process and equipment improvements.
Review and approve equipment and facility design specifications to ensure compliance with regulatory requirements.
Collaborate with cross-functional teams to implement process improvements and troubleshoot issues during the commissioning and qualification phases.
Prepare and review validation documentation, including validation plans, protocols, reports, and standard operating procedures.
Provide technical expertise and support for regulatory inspections and audits.
Stay current with industry regulations and guidelines, and ensure compliance with all relevant standards and requirements.
Mentor and train junior team members on CQV processes and procedures.
Qualifications
Bachelor's degree in engineering, science, or a related field.
Minimum of 3-5 years of experience in CQV within the pharmaceutical industry.
Fluent English written and spoken is a must.
Strong understanding of cGMP regulations and industry guidelines, including FDA, EMA, and ICH.
Experience with commissioning, qualification, and validation of equipment, facilities, and utilities.
Excellent project management skills and the ability to prioritize and manage multiple projects simultaneously.
Strong problem-solving and analytical skills.
Excellent communication and interpersonal skills.
Ability to work independently and as part of a team.
Willingness to travel as needed.
We offer a competitive salary, as well as opportunities for professional growth and development. If you are a highly motivated individual with a passion for ensuring the quality and compliance of pharmaceutical products, we encourage you to apply for this exciting opportunity to join our dynamic team at PharmEng Technology.
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