Join EY and help to build a better working world. As a Staff Consultant, you will support clients by understanding their business needs and contributing to the delivery of high-quality solutions in alignment with EY guidelines and methodologies.
Requirements
- Experience in Quality & Compliance advisory within the Life Sciences domain.
- Experience working with VLMS tools.
- Domain knowledge in Pharmaceutical Quality Control, Quality Assurance, and Regulatory Affairs.
- Strong understanding of CSV principles, GAMP 5, and System Development Life Cycle (SDLC).
- Familiarity with global regulations: USFDA 21 CFR Part 11, EU GMP Annex 11, WHO, HIPAA, TGA, MCC, Anvisa.
- Exposure to enterprise IT systems: Veeva Vault QMS, TrackWise, SAP, LIMS, ELN, MES, Documentum, ValGenesis, Argus, RIMS.
- Hands-on experience with Quality System elements: Deviation, CAPA, Change Control.
- Basic understanding of Data Integrity, Incident Management, and Vendor Management.
- Strong interpersonal, documentation, and presentation skills.
- Good-to-Have Skills: Exposure to business development and client engagement strategies.
- Experience supporting audits and inspections.
- Experience in process optimization and operational efficiency initiatives.
- Ability to align technology with business transformation goals.
- Analytical thinking, adaptability, and decision-making skills.
Benefits
- Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries
- Opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
- Support, coaching and feedback from some of the most engaging colleagues around
