Qms Specialist

Granules India; Hyderabad; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Granules India in Hyderabad seeks Sr. Executive / Assistant Manager - Operational QMS for OSD production QMS, with 8–13 years of experience.

The role focuses on implementing and maintaining QMS across granulation, compression, coating, capsule filling, and packing, ensuring product quality and regulatory readiness at our Gagillapur site. You will lead deviations, OOS/OOT, CAPA, change control, risk assessments (ICH Q9), and RCA using Fishbone, 5Why, and FMEA, while coordinating with Production,

Qualifications

• Experience implementing and maintaining QMS in OSD production.
• Hands-on exposure to USFDA regulated OSD manufacturing plants.
• Experience with deviation, OOS/OOT, CAPA, and change controls.

Responsibilities

• Implement and manage 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 USFDA approved plants only.
• Perform RCA using Fishbone, 5Why, FMEA.
• Prepare, review, and maintain controlled documentation per QMS standards.
• Support 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.

Skills

QMS implementation

USFDA cGMP

CAPA management

Deviation & CAPA handling

RCA methods (Fishbone, 5Why, FMEA)

Audit readiness

Data integrity (ALCOA+)

Risk assessment (ICH Q9)

Cross-functional coordination

Education

B.Pharm / M.Pharm

Job description

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).
• Strong 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,