Review of the BMRs, Quality control, Production, Warehouse and Maintenance records/Logs.
Handling and review of Change Control, Deviation and Incidents.
Preparation of APQR and preparation of online trends.
Monitoring the line clearance activities at plant area
Having experience in handling of regulatory audits i.e. USFDA, MHRA, TGA, CDSCO, WHO etc.
Adherence to SOPs and cGMP Compliance through monitoring on line
Ensuring proper handling, storage & monitoring of inventories as per SOP
Knowledge on process validation and cleaning validation.
Perform annual physical verification of all control samples to ensure their viability Participate in risk assessment meetings
Knowledge on Deviation, CAPA, Change Control and Quality Risk Assessment studies.
Preparing and Reviewing the process validation protocols & reports.
Preparation & Standardization of volumetric solutions and leading the Internal Audits.
Investigation writing skills and know about its tools.
Knowledge on CAPA effectiveness monitoring and evaluation.
Know about current practices i.e. cGMP, regulatory guidelines and current requirements.
Ability to train the employees in the routine QA activities, Quality E applications and SOPs.
Have experience in internal, customer and Regulatory audits
Good communication and presentation skills
Designation & Grade : Senior Executive - E3
Salary: 6,00,000 - 9,00,000 P.A.
Industry:Pharmaceutical & Life Sciences
Employment Type:Full Time, Permanent
UG:B.Sc in Any Specialization
PG:MS/M.Sc(Science) in Chemistry
Doctorate:Doctorate Not Required
Contact Company:LUPIN LIMITED