Horizon Controls Group are seeking a Compliance Engineer, who will be responsible for supporting Compliance activities at our client's single use multi-product biotech facility.
Responsibilities include: · Ensure permanent inspection readiness within the team.
· Support generation/review/approval of CSA deliverables.
· Providing ongoing compliance (GxP, Financial, Data Privacy) coaching and support to all team members.
· 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 · Completion of AIT Investigations, root-cause analysis and CAPA's ·Strong project management skills to support project delivery and operational readiness.
Desirable: ·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 system Contact George on ********** or alternatively email me directly on