Summary: A CSV Lead is required to join the Capital Project Team at our client site in East Cork, a leading pharmaceutical facility.
The successful candidate will lead and guide the CSV qualification of the Gx P Computerised Systems.
The ideal candidate will have knowledge and proficiency in GXP system operation (Automation/IT) and Validation including operational & data lifecycle requirements as they relate to GXP computerised Equipment/Systems.
Responsibilities: Guide and lead the overall CSV approach and validation methodology outlined in the CSV program ensuring it is performed as per relevant site procedures / applicable regulations.
Provide guidance to resolve issues as they arise ensuring solutions and decision making is managed in a collaborative manner Manage stakeholders at monthly reporting meetings.
Prepare and approve all key documentation, providing guidance to ensure team alignment to meet project document schedule.
Work closely with relevant engineering disciplines & vendors of equipment to ensure deliverables meet qualification requirements.
As per site procedures - develop & execute Change Controls and Trackwise records for relevant system updates / changes As required develop (and execute where relevant) User Requirements Specifications, Validation Plans, test protocols and summary reports for GXP system introductions or amendments.
As required Set up of GXP System specifications and Standard Operating Procedures (SOPs) to align with industry standards.
As required draft new or update existing risk assessments to support GXP system operation as they relate to validation/regulatory requirements.
Maintain Requirements Traceability Matrix and generate Data Lifecycle maps as per site requirements.
As required attend system Factory Acceptance Tests in Ireland or abroad, if required Working in a collaborative manner to ensure that key commitments and milestones are delivered on time.
Required to comply with Procedures and Guidelines, regulatory requirements and execute c GMP in the performance of day to day activities and all applicable job functions.
Qualifications & Experience: Relevant qualification (Degree) and/or relevant experience of 10 + years in biotech/pharmaceutical industry qualifying GXP systems.
Previous experience leading a team, managing the team workloads ensuring that all CSV deliverables are achieved as per project schedule.
Previous experience of senior CSV roles held with a solution driven mindset.
Significant project lifecycle experience in CSV validation of GXP systems adopting a risk-based approach.
Authoring CSV documentation from master plans to URS, FRAs, reports etc.
Previous Knowledge with DCS (Rockwell Plant Pax 5.0), BMS (IQ Vision), HVAC, WFI (Veolia), Autoclaves (Fedagari) and Optima filling lines.
Understanding of regulatory requirements as they relate to GXP system qualification and data management best practices.
Experience delivering a complete suite of validation documentation relating to GXP control system introductions / changes.