Chromeleon
Dipali Mehta
QA Executive
Dombivli
Summary
Dedicated Pharma professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
11
11
years of professional experience
5
5
years of post-secondary education
Work History
Quality Assurance (QA)
Shalina Laboratories
04.2017 - 08.2019
- Review of Change controls & Prepared documents
- Review & comments to Deviations
- Investigations of deviations, OOS, Market complaints etc
- Incidence & CAPA (Corrective and Preventive Action) handling
- Making of Corporate PPTs and documentation
- Weekly meeting & follow up with individual stakeholder for documentation & upkeep of QMS documents
- Performed IPQA activities of Capsules, Dispensing, Packing
- Issuance of BMR, BPR, formats to required departments
- Preparation of monthly presentations
- Leading team and working in Agile
- On boarding and mentoring new Team members
- Deviation & Change controls Training
- Investigation & CAPA Training
- Handling Market complaint
Author
Meditab
01.2014 - 12.2016
- Responsible for answering queries related to specifications, analytical method validations raised by regulatory affairs, corporate quality assurance and customers
- Responding to queries of federal authorities like MCC (South Africa), MHRA(UK), TGA (Australia), WHO, CDSCO
- Filling of Change controls & Preparation of documents through Cipdox Software
- Review & comments to specification, IOP, EOP, QCP, GAM prepared by other units
- Filling Deviation & CAPA (Corrective and Preventive Action)
- Review of Pharmacopoeia for any change in pharmacopoeia formulations
- Issuance of Corporate documents to Quality control
- Fulfillment of Corporate Quality Assurance, Regulatory Affairs & Customer requirements during approval of change controls
- Conducted companywide training on good documentation Practices
- Conducted companywide training on usage of Cipdox software
- Mentoring New Joinees in the organization
- Promoted as Reviewer – Chromatography
Reviewer Chromatography
Meditab
01.2010 - 12.2013
- Responsibilities handled in this Position include review of critical tests and functions
- HPLC Review: Instrument Make: Agilent (Chromeleon 6.80 SR 14)
- GC Review: Instrument Make: Agilent (Chromeleon 6.80 SR 14)
- Review of finish products, raw material, stability, working standard qualification and validity evaluation, impurity standard qualification and validity evaluation
- Method validation and method verification of HPLC & GC technique
- Responsible for routine maintenance & calibration of the HPLC & GC
- Investigation & finding out root causes of analytical incidences, Out of Specification, Out of
- Trend along with Lab QA investigation officer & closing the same with proper CAPA
- Review of finished product & stability dissolution analysis on Dissolution Test Apparatus:
- Make: Electrolab
- Planning & handling of Chromatography section
- Mentoring New Joinees in the organization
- Conducted training on Good Chromatographic Practices
- Conducted trainings on integration of chromatographic data, instrument trouble shooting in daily analysis, Preparation of Master Program, Preparation Master methods creation for
- HPLC and GC analysis
- Conducted trainings on Implementation of E-signature of chromatograms
- Joined
Analyst
Meditab
07.2008 - 12.2009
- Wet Chemistry tests
- Testing of water content analysis using KF titrator (Tiamo software)
- Testing of particle size using microscopy
- Performing tests using Viscometer, Density meter, pH meter, Ultraviolet Spectrophotometry
- HPLC and GC Analysis
- Dissolution Test Apparatus handling
- Selection of stability batches
- Upkeep of stability samples
- Preparation of stability summary & preparation of stability protocol
- Highlights of Additional activities during the Tenure:
- External Industrial Trainings Attended
- Laboratory safety & industrial Safety
- Troubleshooting in HPLC & GC
- Current good laboratories practices
- Integration of Chromatograms complying to authorities
- Data Integrity
- Laboratory Information management system (LIMS)
- Challenges in implementing elemental impurity requirements
- Mackenzie Consultancies for below mentioned improvements
- Work simplifications by generating ideas
- Reducing movements in laboratory by streamlining workflow
- Cost cutting by improving solution stabilities of standards & mobile phases, analytical methods and updating specification for single sample preparation by collecting data
- Cost cutting by utilizing stationaries of laboratory (papers, status labels, reference standards etc.)
- Procurement of Acid resistant fuming hood
- Performed Chromatography review of ANDA product at Cipla Kurkumbh
- Conducted Audit of Chromatography section of Medispray Satara
Education
High School Diploma -
Maloji Raje Jr.College
Lonand 06.2003 - 06.2004
Bachelor of Pharmacy -
Satara College of Pharmacy
Satara 06.2004 - 06.2008
Skills
Quality Assurance (QA) Testing
Quality Control
Change Control
Incident Handling
CAPA Handling
Deviation Management
Market Compliance
OOS and OOT Handling
Stability Management
Staff training and development
Knowledge of quality systems
Escalation Management
Accomplishments
- Gold Medallist from Shivaji Univerity Batch of 2008
Software
Tiamo
Chem-Station
Cipdox
EBMS
Microsoft Office
Timeline
Quality Assurance (QA)
Shalina Laboratories
04.2017 - 08.2019
Author
Meditab
01.2014 - 12.2016
Reviewer Chromatography
Meditab
01.2010 - 12.2013
Analyst
Meditab
07.2008 - 12.2009
Bachelor of Pharmacy -
Satara College of Pharmacy
06.2004 - 06.2008
High School Diploma -
Maloji Raje Jr.College
06.2003 - 06.2004