Job Title: Sr. Executive / Assistant Manager US QA Experience: 712 Years Qualification: M.Sc / M.Pharm Job Purpose
To provide
Quality Assurance support to
US-based manufacturing and quality operations , ensuring compliance with
global cGMP, ICH, and regulatory requirements , with a strong focus on
biosimilars . The role supports batch release, quality systems, validation, and continuous improvement initiatives in collaboration with global cross-functional teams.
Key Responsibilities US QA & Compliance
- Provide QA oversight and support to US-based manufacturing and quality operations.
- Ensure compliance with global cGMP, ICH, FDA , and applicable regulatory guidelines across QA activities.
- Review and approve Batch Manufacturing Records (BMRs) and Certificates of Analysis (CoAs) .
Quality Systems & Investigations
- Support and review deviation investigations, CAPAs, and change control activities; ensure timely closure in line with internal SOPs.
- Participate in risk assessments , root cause analysis , and continuous improvement initiatives .
- Contribute to the global harmonization of quality systems and SOPs .
Validation, Tech Transfer & Documentation
- Provide QA guidance for technology transfers , process validation , qualification , and process improvement initiatives .
- Review and approve SOPs, validation protocols, qualification documents , and other technical documentation.
- Maintain electronic and paper-based documentation in compliance with ALCOA+ data integrity principles .
Quality Metrics & Reporting
- Monitor and track key quality metrics and KPIs.
- Prepare and present periodic quality reports for US leadership and stakeholders .
Cross-Functional Collaboration
- Collaborate closely with Manufacturing, Quality Control, Regulatory Affairs, and R&D teams to ensure consistent quality standards.
- Support regulatory inspections, audits, and responses as required for US operations.
Qualification:
- M.Sc / M.Pharm (Mandatory)
Experience:
- 712 years of QA experience in biologics / biosimilars
Technical Skills
- Strong knowledge of cGMP, ICH, FDA regulations , and global quality standards
- Hands-on experience in BMR & CoA review and approval
- Expertise in deviations, CAPA, change control, and quality investigations
- Experience in biosimilars manufacturing, validation, and tech transfer
- Sound understanding of data integrity (ALCOA+) principles
