QA(Validation) 3-5 Years Experience Required

1 week ago

Baddi, India GMH Organics Full time

**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**:
**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**:
**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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