Compliance Engineer
Horizon Controls Group is seeking a Compliance Engineer to support compliance activities at our client's single use multi-product biotech facility.
Responsibilities
Ensure permanent inspection readiness within the team.
Support generation, review, and approval of CSA deliverables.
Provide 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 and access administration, disaster recovery, deviations, incident/problem management, 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 resolve 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.
Complete AIT investigations, root-cause analysis and CAPAs.
Strong project management skills to support project delivery and operational readiness.
Qualifications
At least 2 years experience in planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant.
Thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11.
Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry, PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP environments).
Experience in PLC/SCADA/DCS system.
Contact
Contact George on
or alternatively email me directly on
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