Prachi Kishan Pednekar
Panaji
Summary
I am a seasoned quality assurance resource with a total of 10+ years' experience; and an objective to excel in the field of pharmacy and be a part of the growth-oriented organization with a challenging environment while being resourceful, innovative and flexible.
Overview
10
10
years of professional experience
Work History
SR. EXECUTIVE QUALITY ASSURANCE
Unichem Laboratories Ltd.
01.2019 - Current
- Handling of Audit Compliances and Inspections; Corely involved in compliance reports pertaining to External (Regulatory) and Internal Audits and submissions for audits and inspections;
- Handling and management of deviations and CAPA;
- Handling of Market Complaints; Handling of Quality Risk Management Systems;
- Handling of change controls with detailed evaluation and review of impact assessments pertaining to product, equipment, specifications, facility changes/modifications; etc.
- Handling of Extensive investigations with investigation tools; .
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
- Conducted process and system audits to identify areas of improvement and improvise compliance on par with industry standards;
- Assessed product quality by monitoring quality metrics, reports.
QUALITY ASSURANCE OFFICER
FDC Ltd.
01.2015 - 01.2019
- Handling deviations and CAPA;
- Handling of Corporate and Site change controls;
- Handling of Market Complaints;
- Handling of Stability Studies;
- Handling of compliance reports compilation and submissions for audits and inspections;
- Qualification and Requalification of Purified Water Systems (PWS) and other utilities (as per requirement);
- Product Quality Review (PQR);
- Vendor assessments;
- Batch manufacturing and packing records review;
- Documentation: SOP preparation, issuance, and carrying out review;
- Trainings, and IPQA activities.
MEDICAL WRITER
Cognizant Technology Solutions
09.2013 - 01.2015
- Drafting, QC and medical review of clinical documents; Worked as project-lead for management and delegating project deliverables; Experienced in compilation and finalization of lab reports, narratives and safety update reports.in consideration and compliance with regulatory submissions; Therapeutic areas worked on: pulmonology (asthma, COPD, IPF), oncology (solid tumors, AML, bladder cancers, ovarian cancers, breast cancers, colorectal cancers, etc.), metabolic disorders and laboratory events; Trainings - part of the domain specific training team for delivering trainings to new joiners for domain specific modules; Corely involved in internal team huddles and meetings to support team management.
Education
MASTER IN PHARMACY -
BVDU PUNE
01.2013
BACHELOR OF PHARMACY -
Goa College of Pharmacy
01.2011
Skills
- Quality Management System
- Drafting, Problem solving and Review of investigation
- Metrics preparation and evaluation
- Computer Literacy
- Strong Communication skills
- Interpersonal skills
Personal Information
Title: SR. EXECUTIVE QUALITY ASSURANCE
Timeline
SR. EXECUTIVE QUALITY ASSURANCE
Unichem Laboratories Ltd.
01.2019 - Current
QUALITY ASSURANCE OFFICER
FDC Ltd.
01.2015 - 01.2019
MEDICAL WRITER
Cognizant Technology Solutions
09.2013 - 01.2015
MASTER IN PHARMACY -
BVDU PUNE
BACHELOR OF PHARMACY -
Goa College of Pharmacy
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