QA( Validation) 3-5 years Experience required

Job Title: QA Validation Specialist – Dry Powder Injection

Location: Baddi, H.P
Company: GMH Organics
Job Type: Full-Time | On-site
Department: Quality Assurance / Validation

About the Company:

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