- Provide IT compliance/validation support to the ERMD/AIT Team.
- Ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC), Cyber Security and Data Integrity.
- Prepare plans for remediation of legacy systems and implementation of new systems
- Deliver effective and efficient running of CSV Compliance operations in the ERMD/A&IT team.
- Provide Compliance support, guidance and expertise.
Core Duties & Responsibilities:
- Providing ongoing IT compliance/CSV support.
- Become SME of SDLC/CSV 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, cyber security, data integrity, training etc.
- Generation and execution of documents such as User Requirements Specifications, Design Specifications, FAT, SAT, IQ, OQ, PQ etc.
- Ensure highest Quality & Compliance standards.
- Participate and Comply with Quality Management System (QMS) requirements and regulations, including: EU Annex 11, 21 CFR Part 11, MHRA (UK) GMP Data Integrity Guidelines, Sarbanes-Oxley (SOX ) Regulations.
Minimum Qualifications and Experience:
- Appropriate 3rd level qualification desired.
- Previous experience in a similar role within a highly regulated environment.
- Pharma experience essential.
- Exceptional organizational skills.
- Excellent communication skills.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland.
+353 21 2066178