- Coordinate and execute C&Q activities
- Develop the master list of C&Q test documents and activities.
- Generate C&Q summary reports.
- Ensure the C&Q schedule is developed and maintained.
- Generate all C&Q test documents (C&Q Plan/FAT/SAT/IV/FT/C&Q)
- Attend C&Q coordination meetings.
- Execute running the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
- Involve in tracking and reporting of C&Q status and risks/issues
- Ensures startup of equipment/utilities is completed in a safe and coordinated manner.
- Understand and apply industry specific compliance standards/ regulations to all CQV activities.
- Participate in root cause analysis and investigations.
- Proactively highlight any issues around compliance.
- Participate in internal and external audits and inspections where required.
- Technical qualification at third level or equivalent in Engineering.
- 3-5 years' experience Engineering or Commissioning and Qualification Management in a pharmaceutical or a highly regulated environment
- Technical qualification at third level or equivalent in Engineering.
- Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
- Strong understanding of a risk based approach to commissioning and qualification within pharmaceutical industry
- Demonstrated strong communication skills in dealing with various stakeholders and vendors.
- Extensive knowledge and demonstrated experience in commissioning and qualification for Pharmaceutical / Biotechnology projects Experience
