Compliance Specialist
Category: Bio-Bio-Pharmaceutical
Compliance/CSV Engineer with at least 2 years experience for a contract role in Co. Meath.
Role
- Manage deployment of Global SDLC/CSA and IT Security policies and procedures.
- Ensure supply of all compliance components required to deliver high quality product through tactical planning and execution of project and compliance deliverables, including change-control, periodic reviews, performance monitoring, system administration, access administration, disaster recovery, deviations, incident problem management/investigations, CAPAs, audits, policy deployment, cyber security, data integrity, EHS, training etc.
- Ensure highest Quality, EHS & Compliance standards.
- Active participation in the Tier process and proactively resolving issues.
- Liaise with Compliance Engineers from other areas and support Site Quality Council and other site quality initiatives.
- Coordinate AIT Change-controls, EHS activities and EHS/Quality metrics.
Educations and Skills
- At least 2 years experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant.
- A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11 is required.
- Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments).
- Experience in PLC/SCADA/DCS systems.
Details
LocationMeathLocation typeHybridJob typecontract
