Qms Executive

Global Calcium

4 - 6 years

4 - 5 Lacs

hosur

Posted:8 hours ago| Platform:

Apply

Skills Required

qms qualification change control quality systems quality documentation validation qms implementation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Quality Management System (QMS):

Implement, maintain, and improve the Quality Management System in compliance with GMP and regulatory standards (e.g., USFDA, EMA, WHO).
Review and manage QMS elements such as Deviations, CAPA, Change Controls, Out of Specification (OOS), and Document Control.
Participate in internal and external audits; ensure timely closure of audit observations.
Support quality risk management and periodic review activities.

Validation & Qualification:

Prepare and review validation documents including Validation Master Plan (VMP), protocols, and reports (IQ, OQ, PQ).
Oversee qualification of equipment, instruments, utilities (HVAC, purified water, compressed air), and computerized systems (CSV).
Ensure validation activities are conducted as per cGMP and regulatory expectations.
Review and approve vendor qualification and calibration reports.

Documentation & Compliance:

Ensure documentation practices comply with ALCOA+ principles.
Support regulatory and customer inspections by providing necessary documentation and responses.
Maintain and update validation matrices, equipment lists, and calibration schedules.

Continuous Improvement:

Identify process improvement opportunities to enhance quality and compliance.
Provide training and support to cross-functional teams on QMS and validation processes.

More Jobs at Global Calcium

Stores Associate/Officer

Hosur

5 - 10 yrs

INR 7 - 12 Lacs

Executive - Solvent Recovery Plant (SRP)

Hosur

2 - 4 yrs

INR 4 - 6 Lacs

QA Executive

Hosur

4.0 - 6.0 yrs

INR 6 - 8 Lacs

Purchase Officer

Hosur

2.0 - 4.0 yrs

INR 4 - 6 Lacs

Assistant Manager / Senior Executive - QA

Hosur

8.0 - 12.0 yrs

INR 25 - 30 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.