Skills

WORK EXPERIENCE

16.02.2015–Present

Assistant Manager – Quality Assurance

Cipla Limited.

Plot No. L/139 to L/146,Verna Industrial Area, 403722 GOA (India)

www.cipla.com

▪ Team Leader Analytical Quality Assurance

▪ Handling to QMS (Quality Management System)

▪ Analytical report review PM,RM,Stability,PV,CV,FP and Non-Routine

▪ Handling of Data Integrity issues

▪ Ensuring Quality system compliance as per regulatory audit response

▪ Investigation, trending of Quality Notifications (Change control/ Deviation/ Incidents) initiated during execution products.

▪ Attending cross functional meetings where QA input and oversight is required

▪ Monitoring investigation of analytical incidence OOS,OOT test result and approve the documentation of investigation including action taken

▪ Monitoring of cGLP followed by laboratory personnel during operation to ensure adherence of procedure. Periodic self inspection and technical audit to ensure compliance with the Quality control systems

▪ Supporting Corporate Quality assurance along with unit Quality assurance for contract laboratory audit to evaluate competency of laboratory for cGLP compliance and intended analytical applications

▪ Monitoring and review of unit operation done by auditors to evaluate subject knowledge of analysis and execution of correct procedure as per SOP to facilities the improvement in the system

▪ To operate the Cipla – Quality management system based on the roles and right provided in the applications of deviations and CAPA

Business or sector Manufacturing (Formulations)

07.03.2014 –07.02.2015

Executive – Quality Assurance

Micro Labs Limited.

Plot No. S 155 to159,Verna Industrial Area, 403722 GOA (India)

www.microlabsltd.com

▪ Audit preparation – conducting internal audits/self-inspection and ensuring the corrective action taken for non-conformance.

▪ Participated in investigation conducted on shop floor as investigation team member

▪ Ensuring Quality system compliance as per regulatory audit response.

▪ Verification of impact assessment of change controls

▪ Analytical report review PM,RM,Stability,PV,CV,FP and Non-Routine

▪ Attending cross functional meetings where QA input and oversight is required

▪ Review analytical report and documentation from both technical and compliance perspectives

▪ Involvement in the review of analytical report RM.PM,FP,PV,Stability and Non routine

Business or sector Manufacturing (Formulations)

16.08.2006– 19.02.2014

Senior Officer – Quality Control Loan License

Atra Pharmaceuticals Limited

H-19 MIDC Waluj Aurangabad (India)

www.atrapharma.com

▪ Preparation of standard operating procedure and standard testing procedure

▪ Preparation, execution and reviewing protocol and process validation, Inprocess and finished product stage and other analytical data against the respective specifications

▪ Monitoring and leading the instrumental analysis like HPLC,GC,UV,FTIR and others instruments with subordinates on regular basis

▪ Attending cross functional meetings where QA input and oversight is required.

▪ Maintaining the lab records as per the GMP,GLP and GDP requirements

▪ Allocation of activity planning for inprocess,process validations, finished product raw material and handling the concern as per the requirements

▪ Participated in investigation conducted on shop floor as investigation team member.

▪ To ensure quality system

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