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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 (Gx P, 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?
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 least2 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 1 G/Stamp 4 visa to apply
Please note that for our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1 G 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
Seniority level
Seniority level Mid-Senior level
Employment type
Employment type Contract
Job function
Job function Engineering and Quality Assurance
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