Awareness on current Data Integrity requirements & cGMP requirements, Stability studies. Knowledgeable in handling OOS/OOT/Deviations and QMS (CAPA, CCP etc.) / LIMS Software.
Awareness about cGMP & Pharma industry basic knowledge, Basic GMP, safety and computer knowledge. Handling in plant specific area in shift. Good skill to handle API production equipment
Experiences in HPLC/ GC/ IR/ UV/ Dissolution/ Polarimeter/ Potentiometric titrations/ KF/ PSD by Malvern. Awareness on current Data Integrity requirements & cGMP requirements. Stability studies
Candidate should be capable of operating Analytical instruments such as HPLC, GC,Dissolution Appratus, UV, IR, KF etc. should be aware and capable of Qualitative, Quantitative, Sample, Wet, Routine analysis of drug substances, intermediates, finished products, raw materials etc.