Responsibilities
- Generation and execution of validation protocols and reports (including IQs, OQs, PQs, QAPs, etc.).
- To lead and/or support validation projects and activities on site, as directed and as appropriate.
- To prepare validation plans in line with the strategic goals of the client and to manage timely and compliant delivery of the plan.
- Commissioning and validation of various new technologies and new equipment.
- To develop and execute Commissioning & Qualification lifecycle protocols as per the specific project requirements.
- Leading and supporting SATs.
- Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises, and audits.
- Ensuring manufacturing equipment is qualified in line with production schedule requirements.
- Developing and writing validation procedures according to cGMP and regulatory requirements.
- Generating and executing validation documentation.
- Providing continuous improvement for existing validation procedures.
- Data collation and analysis via sophisticated computer software.
Requirements
- Applicants will have a minimum of 10 years of experience in equipment validation on multiple projects in the pharmaceutical, biopharmaceutical or food sectors.
- Experience with temperature mapping, clean utilities and HVAC qualification are essential.
