05 Nov
|
Talental Consultings
|
India
05 Nov
Talental Consultings
India
- Lead and manage QMS activities in OSD manufacturing as per cGMP, USFDA and regulatory requirements.
- Handle Deviations, CAPA, Change Control, OOS/OOT and Risk Assessment.
- Manage internal, external, regulatory and customer audits.
- Ensure timely investigation, RCA and closure of audit observations and CAPAs.
- Review and approve SOPs, BMRs, BPRs and quality-related documents.
- Ensure Data Integrity (ALCOA+) and GMP compliance.
- Oversee PQR/APQR, customer complaints and product recalls.
- Coordinate with Production, QC, Engineering and Regulatory teams.
- Drive continuous improvement in QMS processes and compliance.
- Lead and manage the QA-QMS team.
📌 AGM- QA - QMS (OSD) (India)
🏢 Talental Consultings
📍 India