Project. Sterile PPC Vial filling Line
for: Lead validation Engineer
Scope of Work & Deliverables
Request for delivery and execution of the following project activities.
PPC Filling Project
The Project role involves working under the Project Manger as a Validation Project Lead.
Involvement in supplier led documentation review and control, and commissioning and validation activities.
Project deliverables; Overall organisational responsible for all Project Quality documentation. The assessment of required Quality plan for new Bosch Filling Line and Telstar Freeze drying system, inclusive of Facility and data control. ( PMS , Eurotherm etc).
Project activities, deliverables and scope include but are not necessarily limited to:
- Report to the Technical Lead and Senior PM on the progress of the project Validation Plan.
- Creation and control planning of documents to priority of project goals.
- Overall control of Quality plan for all elements of the project.
- Active involvement in the execution of test documents.
- Witness and review for testing plans for all Equipment, (NOTE: Must not assume responsibility for design).
- Make direction for PPC Project Manager and Project validation Engineer during IQ/OQ, and be actively involved in the process
- Assemble any documents issued by the Vendor, and collate ready for handover to Operations.
- Represent the project Team at meetings with the Main Contractor’s Commissioning Managers
- Work with PBL’s on other elements of the Project for information system integration such as connection to Eurotherm system i.e. SCADA
- Overall management of CSV Plan in alliance with the Project CSV Engineer (plan and assess required activities thereof.).
- Creation of associated wrap around documents and assessments required for all aspects of CSV project requirements for a GMP project
- An equipment validation engineer for Filling Line and a CSV Engineer will report to the Validation Lead and the project manager.
- Liaise with all members of PPC filling project Team for technical
Project. PPC filling Line
Fully conversant with;
- GAMP4/5 life-cycle
- FDA 21 CFR Part 11
- EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines “Annex 11 (Computerised Systems)”
- ‘Risk-Based’ approach to validation