QUALITY ASSURANCE OFFICER Chennai, Tamil Nadu, India
August 2013 --- April 2014
• Preparing and Compiling the APQR report and statistical trend analysis for the data; Summarize the data collected in APQR preparation.
• Process Validation activities like Validation planning, Sampling during process, Raising test request forms for analysis, Preparation of Process validation Protocols and summary reports based on the Analytical results and Batch documents data.
• Involving in Tracking and highlighting deviations and Incidents in manufacturing operations to the supervisor and raising the Corrective and Preventive Actions, Change controls if required.
• Assisting in Analysis of customer complaints and suitable corrective action.
• Involving during Audit and handling the required documents to the auditors.
• Involving in initiating the change control with necessary document support; execute the approved changes as per the action plan.
• Preparation of master documents (Batch manufacturing records, Batch packing records, Process protocols and reports).
QUALITY ASSURANCE CHEMIST Bangalore, Karnataka, India
December 2011 --- July 2013
• Receiving Online BMR requisition, batch Allocation and reviewing of filled Batch Manufacturing Record.
• Calibrations of all IPQA equipments and maintenance of their log books.
• Preparing controlled documents (SOPS); Conduct distribution, retrieval, archival and destruction of controlled documents.
• Preparing and Reviewing the Product Master File.
• Preparing employee training curriculum, annual schedules; Coordinate with internal trainers and execute the training as per schedule; Maintain, check and update the training records.
• Assess the training evaluation questionnaires; Conclusion of re-training requirements.
• Checking Specifications and complying with the current pharmacopeia/Customer requirements.
AdaptabilityCreative thinkingFlexibilityIndividualityOrganizationProblem solvingSociabilityInnovative thinkingInterest in knowledge
R&DAnalytical Method ValidationAuditingBiopharmaceuticalsCAPAcGMPChange ControlCleaning ValidationClinical trial designClinical trialsCurrent Good Manufacturing Practice (CGMP)Data entryData ManagementEnglishGMPGood Distribution Practice (GDP)Good Laboratory Practice (GLP)Good Manufacturing Practice (GMP)HPLCMedicineNew Drug Application (NDA)Pharmaceutical IndustryQA complianceQuality Assurance (QA)Quality AuditingQuality Control (QC)Quality Management System (QMS)Regulatory affairsReport WritingRisk AssessmentValidationSix SigmaRoot Cause Analysis (RCA)Risk Management