C&Q Lead - Syringe Filling - Pharmaceutical
This vacancy has now expired
Experienced C&Q Lead required for a large scale expansion project.
We need an experienced C&Q Engineer with strong technical knowledge of sterile filling equipment to oversee the commissioning & qualification
Role & responsibilities;
- Liaise with Suite Lead on all C&Q Activities
- Lead the Suites C&Q activities, managing the Suite C&Q resources
- Liaise with the various stakeholders on the Project C&Q team and the overall project
- Participation in C&Q activities
- Review and Input into technical requirement specifications and vendor turnover documentation.
- Participate in C&Q deliverables (System Impact Assessment, Critical Component Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix)
- Manage generation and execution of C&Q documentation (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
- Experience of leading C&Q activities on multiply equipment packages
- Sterile Filling C&Q Equipment Experience
- Knowledge of C&Q documentation required for cGMP process equipment.
- Knowledge of regulations and standards affecting devices, biologics and pharma products.
- Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM
- Strong interpersonal and communication skills (verbal/written)
- Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
- Minimum of 5 years’ experience in commissioning and/or validation of USP/DSP/Facilities/Utilities systems within the Pharmaceutical industry.
- Technical knowledge of Sterile Filling equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.
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The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
CQV Clean Utilities - Biopharm - Carlow Would you be interested in joining one of Ireland's largest pharmaceutical projects? Are able to drive the C&Q clean utilities activities to execution? If
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