- Collect and review all executed BPRs / BCRs with PR, TI & ATR sheets
- Submit reviewed BPRs to IPQA and resolve observations given by IPQA;
- Submit IPQA reviewed BPRs to QA to ensure adequate and accurate documentation of the executed batches within timelines
- Preparation of Change list for equipment / Process. Initiation, daily checking, tracking and timely closure of CCFs in the SAP
- Coordinate with QA to assign the CCF to cross functional teams; Prepare validation documents like BPR, Protocol, Process flow and layouts
- Raise Incidents related to OOS / OOT through SAP
- Prepare the investigation reports for General IRs in coordination with cross functional teams;
- Track CAPA; Ensure Closure of IR before dispatch in order to close any deviations
- Online review of Documents prior to Audit to meet the cGMP compliance;
- Support RA in the DMF filling: Prepare Process description, Process flow, Equipment list and Equipment layout; Prepare SOP's with the help of operating people / System executive;
- Prepare Equipment Performance qualifications after completion of IQ and OQ in order to meet the requirement of quality systems.
- Area Head-Production ,
- Manager-Process Engineering,
- Team Leader – Production Systems,
- Shift Supervisor-Production, Shift Chemist-Production
Good Understanding of the Pharma Industry.
Educational & Experience:
- BSc with experience of 3- 7 years.
- (Experience in production operations, documentation operations)
- Guidelines & SOP's,
- process knowledge,
- SAP knowledge related to production module,
- Communication, People