Develops and maintains clinical software Risk Management Files that include risk management plans, hazard analyses, risk assessments and post market surveillance.
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.
Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products. Sandoz