Senior Executive Quality Assurance

Job Summary

Senior Executive QA – Biologics is responsible for overseeing quality assurance activities related to biologics, manufacturing, ensuring compliance with cGMP, regulatory guidelines (FDA, EMA, ICH), and company quality standards.

Key Responsibilities

 Provide QA oversight for biologics manufacturing operations including upstream,

downstream, and fill-finish processes.

 To handle Training management, Document management and QMS.

 To handle development quality assurance activities.

 Ensure compliance with cGMP, GLP, GDP, and regulatory guidelines.

 Review and approve batch manufacturing records (BMRs), SOPs, protocols, and reports.

 Support technology transfer activities for biologics processes.

 Manage deviation investigations, CAPA, change control, and risk assessments.

 Ensure accurate documentation practices (GDP).

 Review and approve validation protocols and reports (process, cleaning, equipment, method

validation).

 Coordinate cross-functional activities with manufacturing, QC, regulatory affairs, and

validation teams.

 Provide training on quality systems and regulatory requirements.

Qualifications

 Education:

Master's degree in Biotechnology, Microbiology, Biochemistry, or related life sciences.

 Experience:

o Around 5 to 7 years of experience in Quality Assurance in biologics/biopharmaceutical

industry, with experience in biosimilars, biologics

o Required Skills

 Process development Quality assurance.

 Handling of equipment qualifications and process validations.

 Familiarity with regulatory guidelines (FDA, EMA, ICH Q7, Q8, Q9, Q10).

 Strong documentation review and quality systems management.

 Handling document management and training management.