** CQV QA/Quality Consultant ** Immediate Start
1 day ago
Overview
Due to large-scale project wins we now wish to recruit a number of CQV QA candidates to join a highly skilled PM Group team to work on a large Pharmaceutical project in Limerick.
Ideally, the person would work a hybrid scenario of home and 1-2 days onsite. To qualify and work fully remote, the candidate would have to be of a senior level.
We are looking for someone who can start immediately and has experience in this area.
Responsibilities
- Review and approve CQV protocols
- Ensure highest industry standards are incorporated into CQV activities and documentation
- Where necessary, highlight non-compliance within CQV documentation to ensure standard methodologies are maintained.
- Provide feedback and mentorship to the CQV team members on the correct approaches to the completion of CQV documentation
Qualifications
- Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required
- +5 years’ experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems/validation.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.
- Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.
- Understanding of vendor turnover packages (VTOPs) and construction turnover packages (CTOPs) is an advantage
- Excellent interpersonal skills
- Kneat software experience is advantageous but not essential as training can be provided
Why PM Group?
PM Group is an employee-owned, international project delivery firm with a team of 3,600+ people. We are world leaders in the pharma, food, medtech and mission-critical sectors. From our network of offices in Europe, Asia, and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients, and trade partners.
Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.
PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
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