Associate III - QA Associate - Systems & Tools Management

Job Title: QA Associate – QMS (Life Sciences)

Role Overview

Looking for a Quality Assurance professional to support the implementation and maintenance of Quality Management Systems (QMS) within Life Sciences. The role focuses on ensuring compliance with global regulatory standards such as GMP, ISO, and ICH, while maintaining audit readiness and driving process improvements.

Key Responsibilities

1. Manage QMS activities including document control, CAPA, deviations, and change management
2. Maintain and update quality documentation (SOPs, policies, work instructions)
3. Ensure version control and document accessibility in QMS/EDMS systems
4. Support internal and external audits and track audit findings
5. Monitor QMS metrics and generate compliance reports
6. Collaborate with cross-functional teams (Regulatory, Clinical, Manufacturing)
7. Identify gaps and drive continuous improvement initiatives
8. Maintain quality data in systems like Veeva, MasterControl, TrackWise
9. Support system validation, UAT, and upgrades

Required Skills & Experience

1. 2–4 years experience in QA / QMS in Life Sciences domain
2. Strong knowledge of GMP, GxP, ISO standards, regulatory compliance
3. Experience in QMS tools (Veeva, MasterControl, TrackWise)
4. Hands-on experience in document control & audit support
5. Good analytical, communication, and stakeholder management skills