GMH Organics is a leading pharmaceutical manufacturer specializing in sterile dosage forms, including dry powder injectables. We are committed to delivering high-quality, safe, and effective products to improve patient outcomes globally.
Job Summary:
We are seeking an experienced
QA Validation Specialist
to support validation activities for dry powder injectable products. The ideal candidate will be responsible for ensuring compliance with cGMP, regulatory guidelines, and internal quality standards through the execution and review of validation protocols and reports.
Key Responsibilities:
Prepare, review, and execute validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities, and processes related to dry powder injection manufacturing.
Coordinate with cross-functional teams (Production, QC, Engineering) to ensure timely completion of validation activities.
Ensure compliance with FDA, EU, and other regulatory requirements for sterile manufacturing.
Review and approve cleaning validation, media fill protocols, and aseptic process validation documents.
Perform risk assessments and impact assessments as part of validation lifecycle.
Participate in deviation investigations, CAPAs, and change controls related to validation.
Support regulatory audits and inspections as a validation SME.
Maintain validation documentation in accordance with data integrity principles.
Qualifications:
Bachelor's or Master's degree in Pharmacy, Chemistry, Microbiology, or related life science field.
3-6 years of experience in QA Validation within a sterile injectable manufacturing environment; experience with
dry powder injection
is a must.
Strong understanding of cGMP, ICH, FDA, EU, and WHO regulatory guidelines.
Experience in validation of lyophilizers, cleanrooms, autoclaves, and aseptic filling lines is preferred.
Excellent documentation, communication, and organizational skills.
What We Offer:
Competitive salary and benefits package
Opportunity to work with a dynamic and growing team
Career development and training programs
Exposure to global quality and regulatory standards
How to Apply:
Please send your resume and a brief cover letter to rahul@gmh.co.in and also you can share on WhatsApp 7876456719
QA Validation - DPI Application
.
Job Types: Full-time, Permanent
Pay: ?30,000.00 - ?40,000.00 per month
Work Location: In person
Speak with the employer
+91 7876456719
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