LSC have a great contract opportunity for an Automation Compliance to join a leading biotech company based in Meath.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Ensure permanent inspection readiness within the DMO 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Degree qualification (Science, Engineering, Technical).
- Preference for Lean Six Sigma Green Belt.
- Desirable to have qualification in Project Management and Computer Validation.
- Very Strong Collaboration, Compliance and Communication 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
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Please note that for our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa. We regret that we are unable to provide visa sponsorship currently. Thank you for your understanding.
Apply via this advert or contact Paul O'Driscoll at +353214777329 if you have any more questions about this opportunity!
