To Carry out investigations on the Laboratory Incidents, OOC, OOS, OOT, Deviations and Incidents.
Key Responsibilities
"To Carry out investigations on the Laboratory Incidents, OOC,OOS,OOT, Deviations and Provide CAPA as applicable. Responsible to investigate the incidents / deviations occurred across the lab during analysis. Ensuring CAPA effectiveness& verification for the implemented CAPA. Responsible for the preparation/review of change controls in Quality Control. To prepare and review of investigation reports, risk assessments, impact assessments protocols and reports (Hypothesis, method validations, transfers and qualification) as applicable. Responsible to Preparation/review the Certificate of Analysis. Initiation of Laboratory Incidents, OOC,OOS,OOT, Deviations. Responsible to Preparation/review Standard operating procedures/Instrument operating procedures. Reviewing / verification of raw data, analytical results against the specifications.
To implement Corrective and preventive actions as and where applicable. Coordination to head QC in investigating the OOS/OOT/OOC as and when required. Preparation and review of product specifications and Observation data sheet (FP/IP/RM/PM/CS etc). Activities related to document creation/revision and review of SOP/ IOP/GAM/OCP etc. Responsible to provide Site acceptance for the QMS documents received from other sites. Review and maintenance of quality Records. Responsible for the SAP activity. Responsible to review/ approval in LIMS module. Responsible to preparation/ review of quality control documents SAP, Track wise and LIMS activities as per the designated roles."
Educational Qualifications
Required Education Qualification: Msc
Required Experience: 10 - 15 years
📌 Deputy Manager (India)
🏢 BIOCON PHARMA
📍 India
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