Title: Commissioning & Qualification Protocol Generation Lead
Location: Dun Laoghaire
* Lead CQV Engineer responsible for generating and updating as needed the following Master Plans; C&Q Master Plan, Process Equipment and Utilities Plan.
* Also responsible for generating all Project Templates including Pre-delivery Inspection DQ, (PDI), FAT, IV, FT, SAT Protocols, Test Matrix, SAT, IV, FT and Final Reports.
* Aligning with Global SOP's.
* Lead Design Qualification effort from DQ execution to DQ Report issue.
* Liaise with CQV PM and Lead Scheduler to ensure that all document generation prerequisites have been met and are on target and align with global SOP's and report out.
* Lead and manage CQV document generation team ensuring all schedule deliverables are met and report out.
* Manage Kneat electronic validation system, workflow approvals, standardizing templates across the C&Q team.
* Perform Vendor Assessments on all Quality Impacting vendors, lead team through assessments and close-out of actions.
* Solely responsible for ensuring continuity across entire CQV Team in relation to document generation, execution, and final reporting.
* Previous experience of working on and delivering a Verification / Leveraging approach Project for document generation.
* Coordinate and manage all vendors in relation to wrap-around protocols.
* Run and coordinate Weekly Document Generation Meeting, reporting back to CQV PM on deliverables.
Qualifications and Experience:
* 15 years CQV Document Generation experience
* ASTM E2500 / Leveraging Verification process
* Work with all departments and with all levels of the organization, and with contract vendors engaged in design and construction.
* Work closely with other departments.
* Experience with electronic validation systems an advantage
* Minimum of 10 years of experience in the biopharmaceutical industry including experience with design and construction projects for biopharmaceutical manufacturing facilities.
* Minimum 10 years' experience in qualification and validation. Knowledge of biopharmaceutical processing and automation preferred.
* Experience with complex projects and working in or around operating facilities.
* Ability to keep work pace and meet deadlines. Good organizing and planning skills.
* Thorough knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB) required.
* Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
* Proven success working well in a team environment with flexibility to react to changing business needs.
* Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
* Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project, Office, SharePoint, etc.).
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