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
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