About the Role

Looking for an energetic & experienced Subject Matter Expert who have domain knowledge of Quality Assurance, Regulatory Affairs for the position of Business Development of L3 Solutions of Yokogawa focussing on LIMS & eQMS.

Responsibilities

- Business Development of L3 Solutions of Yokogawa focussing on LIMS & eQMS.
- Successfully implementing LIMS & eQMS solutions that includes preparing workflow.
- Devleoping various QMS modules for both API & formulations of Pharma Industry.
- Handling OOS, OOT, Quality Risk Management, Mitigation, CAPA, Deviation Management, Change Control, Learning Management, Document Management etc.
- Facing multiple audits of USFDA, MHRA, TGA, health Canada and WHO audits.

Qualifications:

Bachelor's Degree or Equivalent Level

Required Skills:





- Domain knowledge of Quality Assurance.
- Domain knowledge of Regulatory Affairs.
- 10 to 12 years' experience in successfully implementing LIMS & eQMS solutions.
- Experience in preparing workflow.
- Experience in developing various QMS modules for both API & formulations of Pharma Industry.
- Exposure & hands-on experience on OOS, OOT, Quality Risk Management, Mitigation, CAPA, Deviation Management, Change Control, Learning Management, Document Management etc.
- Experience facing multiple audits of USFDA, MHRA, TGA, health Canada and WHO audits.

📌 Business Development_Software (LIMS & QMS) Solutions (Bengaluru)
🏢 Yokogawa India Private
📍 Bengaluru