Providing ongoing compliance (GxP, Financial, Data Privacy) coaching and support to all team members.
Coordinate AIT Change-controls, EHS activities and EHS/Quality metrics
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.
Ensure permanent inspection readiness within the DMO team.
Liaise with Compliance Engineers from other areas and support Site Quality Council and other site quality initiatives.
Support generation/review/approval of CSA deliverables.
Strong project management skills to support project delivery and operational readiness.
Preference for Lean Six Sigma Green Belt.
At least 2 years experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant.
Degree qualification (Science, Engineering, Technical).
Very Strong Collaboration, Compliance and Communication Skills
Active participation in the Tier process and proactively resolving issues.
Completion of AIT Investigations, root-cause analysis and CAPA’s
Desirable to have qualification in Project Management and Computer Validation.
Experience in PLC/SCADA/DCS systems
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).