CQV Team Leader - Macclesfield
CK Group is recruiting for a CQV Team Leader to join a company in the Pharmaceutical industry at their site based in Macclesfield on a 12 month contract basis.
Our client is one of the worlds leading research driven pharmaceutical manufacturers. They are responsible for the development and manufacture of a range of pharmaceutical products for the treatment of life altering diseases.
This role is located on a state of the art manufacturing facility based in Macclesfield. Their site is easily commutable from Stockport, Stoke-on-Trent, Manchester and Warrington.
The CQV Team Leader will lead a team of C&Q contract resource, for designated work package. This role will be responsible and Accountable for delivery of Commissioning & Qualification (C&Q) for assigned work packages (either utilities, facility, process equipment, (inclusive of DQ, FAT, SAT, Commissioning, IQ, OQ, and RTM).
- Accountable for generating, reviewing and approving C&Q documentation in line with the site GEP and GMP document management systems.
- Accountable for scheduling, tracking, reporting and achieving C&Q deadlines.
- Lead Contractor / Vendor resource to ensure C&Q activities are delivered in compliance with site procedures and in accordance with the project schedule.
- Lead communication of C&Q progress and issues through established project communication methods.
- Collaborate with vendors to ensure the correct standards are delivered to facilitate an integrated approach to C&Q.
- Responsible for the coaching vendor engineers and contractors during C&Q activities.
- Adhereto the project permit to work system or other safety systems to ensure work package C&Q activities are performed safely.
- Perform data analysis to make informed decisions / recommendations around conclusions reached
- Champion a Right First Time / Quality approach to C&Q delivery.
- Drive the timely root cause investigation and preventative action of non-conformances encountered during qualification activities.
- Escalate any significant changes during the C&Q phase with the project team to maintain compliance and delivery programme.
Your Background: To succeed in this role you will have a proven record of delivering activities within the pharmaceutical sector. You will also have extensive knowledge of regulatory requirements and current industry standards pertaining to qualification / validation (EU GMP Annex 1, PIC/S, ISPE Baseline Guide 5, GAMP 5, ISO 14644), quality risk assessment principles and tools, and their application throughout a risk based qualification life cycle.
For more information or to apply for the CQV Team Leader position, please contact Natasha Young on 01246 457739 or email@example.com Alternatively, please click on the link below to apply online now.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45409 in all correspondence.