QC Senior Associate - Systems Analyst
Berkley Group
- Dublin
- Contract
- Full-time
The role may involve carrying out additional work functions that are not described in this specification but are required as per business needs.Responsibilities:
- Triage Management
- Quality Record owner
- Technical writing for investigations
- Ensure timely closure of Quality Records
- SME for Root Cause Analysis and 5 Why methodologies
- Development of robust CAPA and CAPA Effectiveness Verification in conjunction with area SMEs
- Trend Analysis of QC Quality records
- Monthly Metrics Management and Reporting
- Participate in cross functional Investigations Teams
- Lead Continuous Improvement Initiatives
- Contribute to success of QC Goals
- Support NPI/ Lot Release / Stability linked to Quality Records
- Participate in Regulatory Inspections
- Ownership of Change Controls Key Values and Competencies:
- Work in Teams; Ensure Quality; Be Science Based; Collaborate, Communicate and Be Accountable
- Ability to work through Complex Problems
- Excellent verbal and written communication skills including technical writing, presentation, and facilitation skills.
- Ability to work in a fast-paced environment with changing priorities
- Comfortable working under minimal direction Knowledge and Experience
- Hold a third level qualification in a science related discipline
- Have a minimum of 4 years experience in Biopharmaceutical/ Pharmaceutical industries or 2 years in a similar investigator role
- Experience owning Quality Records e.g. Deviation Records, CAPA, ARA and Change Controls advantageous
- Possess key competencies to include planning/organization, problem solving, excellent verbal and written communication, teamwork, flexibility and adaptability