PRAVEEN KUMAR
Amritsar,PB
Summary
Adaptable and Ambitious; Graduate in Bachelor of Pharmacy with total 14.0 years of professional experience of Quality Assurance in inspections that consistently meets the customer standards and specifications. Lead all the Quality Assurance activities to ensure the product manufactured under our supervision is suitable for intended use during its life span. Hardworking, focused on meeting deadlines and monitoring and implementation of quality system as per the updated guidelines. Now Looking for international assignment to enhance my skill and my professional experience.
Overview
14
14
years of professional experience
Work History
Asst. Manager, Quality Assurance
Kwality Pharmaceutical Ltd.
06.2023
Asst. Manager, Quality Assurance
Ravenbhel Healthcare Pvt. Ltd.
06.2022 - 06.2023
Sr. Executive, Quality Assurance
Macleods Pharmaceuticals Ltd.
03.2019 - 06.2022
Manager (Qualification & Validation) in Quality Assurance
Jay Formulations Ltd.
05.2018 - 03.2019
Sr. Executive, Quality Assurance
Psychotropic India Ltd.
06.2016 - 04.2018
Officer II in Quality Assurance
Sun Pharma Laboratories Ltd.
04.2014 - 05.2016
Officer in Quality Assurance
Akums drugs & Pharmaceutical Ltd.
05.2011 - 03.2014
Sr. Chemist in Quality Assurance
East African (I) Oversease
05.2009 - 05.2011
Education
Bachelor of Pharmacy -
SIPER COLLEGE INDIA
2009
Skills
- Strong leadership skills including motivation, organization and constructive mentoring
- Friendly and professional personality to inspire confidence from superiors and subordinates
- Strategic planning experience, Projects handling, including resource allocation and personnel management
- Database skills along with Micro soft office applications
- Monitored to prepare the Site Master File, Quality Manual and Validation Master Plan (Level 1 documents) as per the regulatory guidelines
- To review and approval of master BMR, BPR, SOPs, Protocols and Reports manufacturing and packing technical directions
- Preparation and review of User Requirement Specification (URS), Functional specification, GXP Assessment, GAP Assessment, Initial Risk Assessment, IQ, OQ, PQ, FRA, TM, VSR
- Preparation and review of SIA, SRA, DQR, DSR, QRA, FAT, SAT, IQ, OQ, PQ, RTM
- Strong knowledge about the execution of HVAC validation, Water System validation, Compressed air validation etc as per the cGMP requirements
- Preparation and review of process validation protocols and reports
- Preparation and review of cleaning validation protocols & reports
- Preparation and review of DEHT & CEHT study protocols and report
- Preparation and review of hold time study protocols and reports
- Guided to prepare the Failure Mode Effect critical Analysis documents, Risk analysis documents against the facility, equipment and products Reviewed the FMECA of individuals at a regular time interval
- Handling of Deviation, Change control and CAPA
- QMS Document review and Gap analysis
- Handling of batch release system for formulations
- Handling of market complaints, product return goods and recall
- Provide the required training ie functional, cGMP, On job training and management and its compliance
- Scheduling, execution and report preparation for Internal & External Audit and Audit compliance
- To implement corrective measures based on self-inspection, deviation, failure investigation
- Preparation and review of PQR
- Monitoring of shop floor activities, from dispensing to dispatch
- Conduct the quality council meetings at regular intervals
- Intimated to corporate quality for any critical non-conformances observed in plant level along with compliance Approval also taken from CQA head if required
- Attained the daily meetings conducted in plant related to production planning and discussed on non-compliances if observed
- Implemented the quality communication received from Corporate and send the feedback to them after implementation
Audit Faced
- USFDA
- MHRA
- WHO (Geneva)
- PPB (Kenya)
- FDA (Uganda & Tanzania)
- Ukraine
- EFDA (Ethiopia)
- PIC/S
- ANVISA
Other Audits
- Cipla
- Alkem
- Sun Pharma
- Steride
- Sanofi
- Lupin
- Intas
- Teva
- Abbott India Ltd.
Personal Information
Date of Birth: 03/17/89
References
Mr. Amandeep Mohey, amanmohey@gmail.com, 0707258593
Timeline
Asst. Manager, Quality Assurance
Kwality Pharmaceutical Ltd.
06.2023
Asst. Manager, Quality Assurance
Ravenbhel Healthcare Pvt. Ltd.
06.2022 - 06.2023
Sr. Executive, Quality Assurance
Macleods Pharmaceuticals Ltd.
03.2019 - 06.2022
Manager (Qualification & Validation) in Quality Assurance
Jay Formulations Ltd.
05.2018 - 03.2019
Sr. Executive, Quality Assurance
Psychotropic India Ltd.
06.2016 - 04.2018
Officer II in Quality Assurance
Sun Pharma Laboratories Ltd.
04.2014 - 05.2016
Officer in Quality Assurance
Akums drugs & Pharmaceutical Ltd.
05.2011 - 03.2014
Sr. Chemist in Quality Assurance
East African (I) Oversease
05.2009 - 05.2011
Bachelor of Pharmacy -
SIPER COLLEGE INDIA
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