Quality Engineer Risk Management
Resume:
AISHWARYA KUMAR MEHTA
QUALITY ENGINEER
CONTACT
14C, GMS Home-5
Peermushalla, Zirkpure
Mohali, Punjab (India)
**************@*****.***
*****************@*****.**.**
PROFILE
Deep experience in leading the delivery of actions relating to the QMS, including documentation of control procedures, records management and recording of decisions and evidence as well as knowledge in applying statistics, metrics, data analysis and reporting. EDUCATION
C.E. (Chartered Engineering) in
mechanical stream. Year 2002
Instituted of Mechanical Engineering
(I) Mumbai, India
KEY SKILLS
Technical Knowledge
Analysis/Critical thinking/Problem-
solving
Excellent communication
Innovation
INTERESTS
Literature
Environmental conservation
Art
Yoga
Skiing
Travel
AUDIT
EXPERIENCE
USFDA
PADMA
EMA
INVISA
Heath Canada
Russia Audit
MCC
EXPERIENCE
DEC-2011 - PRESENT
Fresenius Kabi Oncology Ltd • Baddi (H.P), India
Quality Engineer: -
• Responsible to develop and implement quality polices as regulatory requirements.
• Ensure compliance with regulatory requirements, such as FDA, EU and ICH guidelines.
• Prepare response to regulatory inspections and audits.
• Maintain and improve the quality management system, including documentation, training and audits.
• Review/Prepare of all critical machine / system SOPs against GMP / OEM recommendation and update accordingly, if required.
• Maintain/ track on distribution of GMP documents/ formats and reconcile.
• Ensure the compliance/closer of documentation of quality related activities like Operational, Planner for Maintenance, and Calibration activity.
• Performed GAP assessment/Evaluation the current procedure and practices w.r.t actual. Based on assessment, same will be implemented
• Preparation of Risk assessment, Data integrity risk assessment
(DIRA), investigation reports, SOP’s (Caliber DMS) and Validation documents.
• Review vendor documentation Like SET, FAT, IQ, OQ.
• Responsible for Develop and track quality metrics to monitor performance and identify areas for improvement.
• Responsible for Investigate and implement corrective actions to address quality issues and prevent recurrence.
• Performed breakdown analysis and appropriate action taken like procedure control to prevent recurrence.
• Maintained and tracking on KPI (Kye performance Indicators) for department.
• Plan and schedule routine Audit in area to check the compliance and effectiveness of the implemented process and procedures.
• Plan and Execute training in refresher training, procedural training in LMS.
• Layout review.
SOFTWARE SKILLS
DMS (Document Management
System)
Trackwise
Caliber ESM (Maintenance
Software)
LMS (Training Software)
PERSONNEL
DETAILS
Name: Aishwarya Kumar Mehta
Date of Birth: -06/01/1977
Contact Number: 959-***-****
Current Salary – 17.67 Lac per
annum CTC
Expected Salary: Negotiable
General Engineering: -
• To maintain and follow practices related to Safety, Health and Environment in the work premises.
• Overall responsibility for operation and maintenance of BMS, HVAC, super chiller. Water systems (Like RO Generation system, Pure steam generation, WFI generation) and Air conditioner.
• Shift scheduling and men power planning on day-to-day basis.
• To plan manage and ensure the required utility operation and maintenance activity smooth operation at site.
• To ensure the GMP/GXP documentation and support in all automation related activities.
• Plan and organize the preventive maintenance HVAC and water system equipment’s.
• Closed coordination with respective area personnel’s for arranging the water system equipment’s for preventive maintenance, routing maintenance, sanitization etc. activity purpose.
• Attainted breakdown and troubleshooting of fault in water system equipment’s.
Project Engineering:
• Oversee project execution, ensuring compliance with regulatory requirement and company standards.
• Track project progress, identify and mitigate risk and take corrective action as taken.
• Review layout/drawing and corrected according to the requirement of project.
• Ensure project compliance with GMP regulations.
• Collaborate with cross functional teams.
• Monitor and control project expenses, identifying areas for cost reduction and optimization.
• Develop and deliver training programs and documentation to ensure smooth project execution.
• Develop and manage project plans, timelines and budgets. PROJECT AND VALIDATION ENGINEER • APR-2007- DEC-2011 Hemmo Pharmaceutical Pvt. Ltd • Mumbai, India
Working Profile:
• Routine Maintenance and Operational of water system and HVAC s system.
• Working on energy saving projects to minimize the operational cost of HVAC system.
• Planning and tracking on Preventive maintenance and calibration on day to day basis.
• Performing Commissioning and validation for new manufacturing facility and qualification protocol.
• Develop risk assessment, deviation response and summary reports for qualification.
• Execute equipment validation for facilities, cold room, HVAC, water systems, Autoclave, DHS, Reactors, Centrifuge etc.
• Monthly meeting planning and tracking on implementation for discussed points action points from stack holders
• Manage deviation and non-conformance report and investigations.
• Management of deviations related to Documentation control.
• Provide support ensuring external audit readiness and during external audits and corporate internal audits.
• Oversight of site Training activities.
• Oversight of Regulatory compliance activities.
• QMS compliance and handing regulatory audits USFDA etc VALIDATION & DOCUMENTATION ENGINEER • APR 2002-
APR 2007
IPCA Laboratories Ltd. Ratlam (M.P), India
• Performing Commissioning and validation for new manufacturing facility and qualification protocol.
• Execute equipment validation for facilities, cold room, HVAC, water systems, Compressed Air/Nitrogen system etc.
• Monthly meeting planning and tracking on implementation for discussed points action points from stack holders.
• Manage deviation and non-conformance report and investigations.
• QMS compliance and handing regulatory audits USFA etc.
• Handing Regulatory Audits like WHO, USFDA etc
• Performing Re-Qualification/ Validation of process and utility equipment’s Like Compressed Air, Nitrogen Generation systems, HVAC, Jet mill, Powder Processing system.
Contact this candidate