Are you passionate about Quality Assurance in the biopharma and biosimilar industry?
GeNext Genomics Pvt Ltd, a leading biotechnology company specializing in monoclonal antibodies (mAbs) and protein biosimilars, is hiring a full-time Executive QA in Nagpur, Maharashtra.
This position offers a chance to work at the forefront of biologics research and regulatory compliance, ensuring product quality and adherence to GMP standards.
Key Responsibilities
- Manage issuance, archival, and retrieval of QA and GMP documents.
- Handle control copies and destruction of obsolete GMP documents.
- Prepare and track all QA documentation, including SOPs and logbooks.
- Maintain QA backups and ensure data integrity compliance.
- Participate in line clearance, dispatch, and deviation handling.
- Support change control, CAPA management, and quality audits.
- Collaborate with cross-functional teams to uphold regulatory standards.
Required Qualifications
- M.Sc. or M.Pharm. (preferably with specialization in Regulatory Affairs or Documentation).
- Prior experience or understanding of QA aspects in biosimilars and recombinant protein projects.
- Excellent communication, attention to detail, and organizational skills.
- Knowledge of GMP, CAPA, SOP management, and data integrity principles.
Preferred Competencies
- Quick learner with strong analytical and documentation skills.
- Fluent in English (written and spoken).
- Team-oriented, reliable, and punctual.
Benefits of Joining GeNext Genomics
- Opportunity to work in an innovative Biopharma R&D environment.
- Exposure to monoclonal antibody and biosimilar projects.
- Skill development in quality compliance and regulatory frameworks.
- Supportive workplace fostering continuous improvement.
How to Apply
Interested candidates can apply by sending their CV and Letter of Intent to:
📩 info@genextgenomics.com
Location: Nagpur, Maharashtra, India
Employment Type: Full-time, On-site