Analyst - Quality Assurance (Manufacturing QA)

Roles & Responsibilities:
• Perform In-Process Quality Assurance (IPQA) activities including dispensing checks, line clearance, and material reconciliation as per cGMP
• Review and approve MBRs, BPRs, and support batch release of Drug Substance (DS) and Drug Product (DP)
• Prepare, review, and approve APQRs, process validation and cleaning validation protocols/reports
• Develop equipment qualification strategies; review URS and execute/approve IQ/OQ/PQ
• Support facility design reviews, cleanroom qualification, and validation activities
• Manage GMP documentation through Document Control; initiate and revise SOPs, policies, and QMS documents
• Deliver cGMP training and support internal audits and regulatory inspections
• Handle QMS activities including deviations, change controls, OOS, CAPA, risk assessments, and digital quality platforms (ELN, LMS, DMS)

Qualification:
• B.Tech/M.tech / B.Pharm / M.Pharm /M.Sc (Biotechnology, Biopharmaceuticals, Biological Sciences, QA or related fields)

Experience:
• 4–8 years of experience in Quality Assurance (Biotech / Biologicals)
• Experience in biosimilars preferred; cell & gene therapy exposure is an advantage

Skills:
• Strong knowledge of IPQA, batch release, and sterile manufacturing
• Expertise in cGMP, GLP, GDP, data integrity, ICH guidelines
• Hands-on experience with deviations, change control, CAPA, and validation
• Familiarity with electronic QMS systems and digital quality tools
• Strong communication, teamwork, and continuous improvement mindset

About the Organization:
Immuneel Therapeutics is a pioneering Indian cell and gene therapy company developing personalized immunotherapies, offering a purpose-driven, agile environment to contribute to next-generation cancer treatments.