To ensure cGMP compliance at the shop floor for Drug Substance (DS) manufacturing through effective line clearance, documentation review, in-process oversight, and quality systems activities.
QA professional experienced in GMP documentation review, process and cleaning validation, QMS management (Change Control, Deviation/Event, CAPA), analytical data review, SOP management, and regulatory compliance activities.
Area of Specialization : Pharmacology/Pharmaceutical Sciences/Life Sciences/Biotechnology. Masters in Degree from recognized university or equivalent AND 3 years experience in research & development in industrial and academic institutions or science & technology organization. CSIR-Innovation Complex, Mumbai
B.Pharmacy from a recognized Institute OR 10+2 with science stream from a recognized Board, AND Approved Diploma in Pharmacy from an Institute recognized by the Pharmacy Council of India and registered as Pharmacist under the Pharmacy Act 1948. ECHS INS Hamla
M.Sc./M.Tech./M.Pharm. or equivalent Master’s degree in biotechnology with minimum 55% marks or equivalent CGPA from a recognized University/Institution. Candidates possessing NET/GATE/DBT-BET or other nationally recognized eligibility qualification. Somaiya Vidyavihar University, Mumbai
Case Intake, Data enter, Quality review information received pertaining to the case in the database. Refer to the Data entry conventions for any questions while entering the data.
Post Graduates in Life Sciences / Pharmacy / Statistics/ Social works/Sociology/BAMS, BSMS, MD in AYUSH with at least 55% marks with 3 year of post qualification experience in the related field. ICMR-NIRWoH, Mumbai
Masters Degree in Natural or Agricultural Sciences / MVSc or Bachelor’s Degree in Engineering or Technology or Medicine from a recognized University or equivalent. BRIC-National Centre for Cell Science, Pune
Xogene combines regulatory expertise with advanced technology to automate complex processes in clinical trial disclosure. As trusted experts with comprehensive knowledge of global regulatory frameworks, we deliver efficient data transformation and regulatory compliance for our clients, streamlining workflows through our AI and agentic networking capabilities. We're committed to leveraging technological solutions to advance clinical trial transparency.