We are hiring : Sr. Executive / Assistant Manager - Operational QMS (OSD Production QMS)

Work Location: Gagillapur, Hyderabad
Experience: 8 13 Years(OSD Only)
Qualification: B.Pharm / M.Pharm

Job Responsibilities:

- Implement and manage Quality Management Systems (QMS) in OSD Production (Granulation, Compression, Coating, Capsule Filling, packing).
- Initiation, Designing, Handle & closure of Deviations, Incidents, OOS/OOT, CAPA, Change Control, Risk Assessment (ICH Q9).
- Ensure compliance with USFDA cGMP requirements in USFDAapproved manufacturing plants only.
- Perform RCA using tools like Fishbone, 5Why, FMEA.
- Prepare, review, and maintain controlled documentation as per QMS standards.
- Support and face USFDA audits, regulatory inspections, and customer audits.
- Monitor data integrity (ALCOA+), GDP, and SOP compliance.




- Coordinate with Production, QA, QC, Validation, and Regulatory Affairs teams.
- Conduct GMP and QMS training for production personnel.
- Drive continuous improvement, compliance culture, and audit readiness.

Mandatory Requirements:

- Hands-on experience in USFDAregulated OSD manufacturing plants (mandatory).
- Solid exposure to initiation, preparation, handling and closure of OOS, OOT, Deviation & CAPA.
- Experience in audit responses, observations, and CAPA effectiveness checks.

Industry: Pharmaceutical / OSD Manufacturing (Only)
Function: Quality Management System (QMS) Production Support,

Send CV to: [email protected]

📌 Qms Specialist (Hyderabad)
🏢 Granules India
📍 Hyderabad