A Commissioning & Qualification Manager is required by CareerWise Recruitment for our Carlow based Pharmaceutical client. If you have experience in Drug Product Formulation then this is the position for you !!!
Role of this position
- Lead and coordinate a commissioning and qualification program for Drug Product formulation and filling, clean and black utilities, support services, and laboratory equipment.
- Lead the planning and tracking of activities, working with the assigned C&Q partner.
- Liaise with the various stakeholders on the C&Q team and the overall project to ensure clear communication between all parties.
- Participation in GMP design reviews (DQ, CLIA etc), as required.
- Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
- Owner of pre-requisite C&Q Strategy and deliverables (System Level Impact Assessment, Component Level Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix).
- Oversees the generation, execution and approval of C&Q documentation in electronic format in KNEAT (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
- Review of CCRs and TOPs. May require travel to vendor shops and frequent communication with vendors to ensure documentation deliverables are per the VDRs
- Generate C&Q change controls (FPIDCNs and PCNs) and drive their closure in a timely manner. Ensure non-conformances & deviations are minimised and closed out in a timely fashion.
- Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
- Minimum of 5-8 years' experience in commissioning and/or validation of Drug Product/Facilities/Utilities systems within pharmaceutical industry.
- Technical knowledge of utilities, filling and formulation equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.
- Minimum 5 years of experience with supervisory, project management and budget management are required.
Please call Louise Mulligan today for further information on 0949003979 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)