Micro Crispr Pvt. Ltd.
Quality Assurance Specialist
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Job Opportunity at MicroCrispr Pvt. Ltd
We at MicroCrispr Pvt. Ltd are looking for dynamic personnel to join the vibrant QA team for cell and gene therapy (CGT) and other Advanced Therapeutic Medicinal Products (ATMPs). If you are a potential fit, kindly share your resume at vishal.kapadi@microcrispr.com & deepak.sharma@microcrispr.com
Opening for QA Verticals:
- IPQA (In-Process Quality Assurance)
- AQA (Analytical Quality Assurance)
- QMS (Quality Management System)
- Engineering QA/Qualification
- DMS / Documentation QA
- DQA (Development Quality Assurance)
- Data Integrity (DI Officer)
- Computer System Validation (CSV QA)
- Clinical QA
- GLP QA
- Pharmacovigilance QA
- Training QA
- Audit & Compliance QA
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Key Responsibilities
- Ensure compliance with cGMP, GDP, GLP, GCP and regulatory guidelines.
- Support Quality Management System (QMS) activities including deviations, CAPA, change control and investigations.
- Perform review and approval of quality documents and records.
- Conduct shop floor monitoring and compliance checks where applicable.
- Maintain data integrity and proper documentation practices.
- Support internal audits, regulatory inspections and compliance activities.
- Coordinate with cross-functional teams such as Production, QC, Engineering and R&D.
- Ensure timely closure of quality observations and corrective actions.
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Qualifications
- B.Tech Biotechnology/M.Tech Biotechnology/M.Sc in Life Sciences/M.Pharma etc.
- Experience
- 1 – 10 Years of experience in CGT (Exp will be preferred) Pharma / Biotech / Biopharma industry.
Key Skills
- cGMP / GDP / GLP / GCP knowledge
- Quality Management System (QMS)
- Documentation & Data Integrity
- Audit & Compliance
- Regulatory understanding
Location
- Vapi, Gujarat
📩 Interested candidates may share their updated CV at: vishal.kapadi@microcrispr.com & deepak.sharma@microcrispr.com
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