Use This TemplateProfessional Summary
Resourceful, enthusiastic and adaptable Pharmacy Postgraduate with a practical hands-on approach who always perseveres to achieve and deliver the best results. Highly-motivated, focused professional with 9 years of experience in Pharmaceutical Arena. Consistently participates in building strong organisation and continuous improvement initiatives. Strong Quality Management skills with keen ability to multi-task in a fast-paced, results-driven environment.
Employment history
Quality Assurance Manager, Davis and Sons. Lake Maudieland, Louisiana
Aug. 2014 – Present
- Responsible for the Batch release for sale after reviewing the Batch Manufacturing & Packaging Records, In-process Quality Control & Finished product analysis reports.
- Responsible for review, approval & authorisation of the system for review, approval, distribution, revision and destruction of SOPs and other controlled documents.
- Responsible for review and approval of SOPs, Work Instructions, General Test Procedures, Product Specifications and Methods of Analysis.
- Responsible for the review and approval of key documents such as Quality Manual, Annual Product Quality Review, Batch manufacturing and Packaging records, Process Validation, Analytical Method Validations, Equipment Qualifications, Validation Master Plan, Stability Reports etc.
- Responsible for handling of Market Complains, Product Recalls, Change Controls, Deviations, NCR, Incidents, CAPA, OOS and OOTs etc.
- Responsible for conducting Root Cause Analysis to remedy Deviations having negative impact on Product Quality.
- Responsible for the development & approval of Artworks.
- Responsible for coordination and execution of the internal audit program.
- Responsible for the planning, review and approval of equipment qualification protocols & reports.
- Responsible for the preparation & implementation of Validation Master Plan.
- Responsible for organising Self inspections, Quality audits & GAP analysis with follow ups.
- Responsible for the Implementation and compliance with the cGMP requirements from Material receipt till product dispatch.
- Responsible for monitoring of In-process Quality Assurance activities.
- Responsible for conducting & monitoring GMP Trainings as per the training calendar.
- Responsible for co-ordination between Production, Quality Control Laboratory and Warehouse.
- Responsible for the establishment of Preliminary Vendor Selection and Vendor Qualifications.
- Responsible for implementation of Quality Risk Management throughout the product life cycle from Product Development till product dispatch & distribution.
- Impact Analysis during evaluation of Change Controls, Deviations, Incidents and other Quality Management Systems.
- Review of Stability data and assignment of shelf life.
- Successfully participated & represented the organisation in many Regulatory inspections such as WHO GMP, STATE GMP, NDA – UGANDA, MOH – DR CONGO, FMHACA – ETHIOPIA, FDA – GHANA, NMPB – SUDAN, NAFDAC – NIGERIA, TFDA – TANZANIA, PPB – KENYA, PMPB – MALAWI, FDA – PHILIPPINES and also many customer audits.
- Responsible for Product Permissions, WHO GMP COPPs and Free Sale Certificates applications to State Licensing Authority.
- Responsible for the Manufacturing License and WHO GMP renewal applications to State Licensing Authority & National Regulatory Authority with related documentation.
- Responsible for Loan License applications to State Licensing Authority with related documentation.
- Responsible for the other miscellaneous Regulatory Applications such as Performance Certificate, Non-Conviction Certificate and Whole Sale License to State Licensing Authority.
- Responsible for Export NOC applications and applications for the extension of shelf life of the products to State Licensing Authority & National Regulatory Authority with related documentation.
- Responsible for the review of Product registration dossiers as per CTD and ACTD guidelines for many African and ASEAN Countries.
- Successfully handled queries raised by many International Regulatory bodies like TFDA – Tanzania, NDA – Uganda, FDA – Myanmar, PPB – Kenya, NDSO – Lesotho, PMPB - Malawi etc. while processing the product registration applications.
- Responsible for Tender participation applications and related documentation.
Quality Assurance Executive, Hauck-Volkman. West Columbus, North Dakota
Jun. 2012 – Aug. 2012
- Responsible for review and approval of SOPs.
- Responsible for review & approval of Process Validation, Method Validation and Cleaning Validation Protocols & Reports.
- Responsible for issuance of Batch Manufacturing & Packaging Records.
- Responsible for review & approval of SMF (Site Master File) and DMF (Drug Master File).
- Responsible for carrying out line clearance checks.
- Responsible for review of Batch Processing Documents.
- Responsible for the review & approval of Master Validation and Calibration Plan and monitoring the execution of all validations & calibrations activities accordingly.
- Responsible for Additional Products Permissions and WHO GMP COPP applications to State Licensing Authority.
- Responsible for carrying out Self-Inspections and Quality Audits.
- Successfully Participated in WHO GMP and many vendor audits.
- Responsible for the Manufacturing License and WHO GMP renewal applications to State Licensing Authority & National Regulatory Authority with related documentation.
Quality Control Officer, Senger-Kiehn. Treasamouth, Wisconsin
Nov. 2009 – Jul. 2010
- Responsible for carrying out Quality Control tests mentioned below on Finished Products, Raw Materials and Intermediates using HPLC, UV, Disintegration Test Apparatus, Dissolution Test Apparatus, Friability Test Apparatus, Hardness Tester, Karl Fischer Titrator and FTIR.
- % Assay
- Uniformity of Dosage Units
- Uniformity of Weight (mass)
- % Friability
- Hardness
- Dissolution
- Disintegration
- % Water & % LOD
- Drug identification using FTIR
- Related Substances (Impurities)
- Responsible for Calibration of instruments, maintaining records, preparing COA and reporting to QC manager.
- Responsible to make sure that GLP is maintained in the laboratory.
- Responsible for the review of Batch Processing documents and SOP's.
- Responsible for carrying out sampling & testing during Process Validation activities.
- Responsible to prepare and validate method of analysis.
- Responsible to perform and document Analytical Method Validations and Stability Studies.
- Responsible for the sampling of products for QC Analysis.
- Responsible for maintaining the product inward and outward register.
- Responsible to carry out In-process Quality Control testing at predefined frequency.
- Responsible for review & compilation of Batch Processing Records along with Analytical documents for the final review by Qualified Person before batch release.
- Successfully Participated in a MHRA Inspection.
Education
Sawayn Academy, Lake Rivka, South Carolina
Master of Science, Formulation Science, Feb. 2008
Southern Harvey, Port Antwanchester, Minnesota
Bachelor of Pharmacy, Pharmacy, Jul. 2006
Languages
English
Fluent
Hindi
Native speaker
Gujarati
Native speaker
Skills
Quality Control
Experienced
Pharmaceutical Chemistry
Experienced
Analytical Chemistry
Experienced
Research and Development
Expert
Formulation and Development
Expert
Current Good Manufacturing Practices
Expert
Quality Risk Management
Expert
Quality Management System
Expert
Pharmaceutical Quality System
Expert
Quality Assurance
Expert
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