Sayali Borkar
Pune
Summary
Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
13
13
years of professional experience
Work History
Head QA & RA
Quantime World Pvt. Ltd
Pune
03.2019 - Current
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to services.
- Initiation & implementation of QMS
- Expertise in handling customer, internal & regulatory audits
- Knowledge of GMP, GCP & GDP
- Maintained updated knowledge through continuing education and advanced training.
- Accountability for every process, client issues & achievements.
- Expertise in Vendor Qualification, Depot Qualification
- Collaboration with depot teams for global project management
- Authorized to act as a final decision maker in all issues and action plans.
Associate Manager QA & QC
Bilcare Global Clinical Supplies
Pune
03.2013 - 03.2019
- Monitored customer complaints and provided timely solutions to improve customer experience.
- Handled responsibilities successfully in manager's absence.
- Provided second checks in all incoming material inspections, daily operational quality control checks.
- Training management
- Internal audits, CAPA, deviation & change management
- FDA approved competent techinical person
Microbiologist
Supriya Life Sciences
Chiplun
03.2011 - 02.2013
- Assisted with the development of laboratory protocols related to sample processing, analysis, and reporting of results.
- Analyzed data from environmental samples to determine levels of microbial contamination.
- Monitored microbiological tests including Microbial limit test, total plate count, bioburden testing.
- Maintained a clean and safe working environment by adhering to established safety procedures.
- Carried out quality control checks on materials used in the laboratory setting according to established standards.
- Interpreted test results accurately ensuring that all data is reported properly.
Education
Master of Science - Microbiology
Shivaji University
Kolhapur06-2010
Skills
- Team work & Collaboration
- Communication
- Recordkeeping
- Microsoft Word
- Computerized system validation as per 21 CFR part 11 compliance
- Global Project Management
- Well versed with ICH guidelines
- Ability to handle IWRS, inventory management software as per requirement
Languages
English
First Language
Affiliations
Reading
References
References available upon request.
Timeline
Head QA & RA
Quantime World Pvt. Ltd
03.2019 - Current
Associate Manager QA & QC
Bilcare Global Clinical Supplies
03.2013 - 03.2019
Microbiologist
Supriya Life Sciences
03.2011 - 02.2013
Master of Science - Microbiology
Shivaji University
Similar Profiles
Priyashree S. KhotrePriyashree S. Khotre
Sr. QA Manager at Quantime World Pvt. LtdSr. QA Manager at Quantime World Pvt. Ltd
RAHUL SINGHRAHUL SINGH
Business Development Executive (Contract) at Vibrant World Logistics Pvt. Ltd.Business Development Executive (Contract) at Vibrant World Logistics Pvt. Ltd.
HariPreethi SoundappanHariPreethi Soundappan
Consultant at World Line India Pvt LtdConsultant at World Line India Pvt Ltd