Anagha Sardessai
Ponda
Summary
Dedicated and detail-oriented Quality Assurance professional with experience primarily in SOPs, Training, Local licensing activities, IPQA, Batch record review and Quality agreements.
Overview
14
14
years of professional experience
Work History
Corporate QA
Indoco Remedies Limited
Verna- Goa
09.2023 - Current
- Managed quality agreements with customers, manufacturers, and contract testing laboratories.
- Handling of Management review meetings to track compliance, CAPA progress, and quality performance.
- Conducted site rounds to monitor GMP practices and identify improvement areas.
- Review of site QMS and site procedures and to ensure accuracy.
Quality Assurance
Unichem Laboratories Ltd.
Pilerne
07.2015 - 10.2021
- Managed local FDA licensing activities for Goa site, preparing applications and ensuring timely availability of product manufacturing licenses, test licenses, WHO-GMP certificate renewal, plant manufacturing licenses, COPPs, and import licenses.
- Departmental Training coordinator.
- Acted as the Functional Administrator for the department and contributed to the successful implementation of SAP successfactors for employee training.
- Oversaw management of SOPs, including review, updates, issuance, and retrieval.
- Management of Retention samples.
- Executed Mock Product Recall activity.
- Managed issuance and retrieval of documents in the document storage area.
Quality Assurance
Indoco Remedies Ltd.
Verna
09.2012 - 07.2015
- Handled IPQA activities in Tablet Packing area.
- Reviewed Master Batch Packing records and executed Batch packing records.
- Handled local FDA related licensing activities for the plant: Preparation of applications and ensuring timely availability of Product Manufacturing licenses, Test licenses, Renewal of WHO-GMP Certificate and COPPs.
- Handled Market complaints.
- Management of Retention samples.
- Prepared and compiled Annual Product Review of various products.
- Audits Faced: WHO-GMP, USFDA, MHRA, MCC, EMA, ANVISA and various customer audits.
Education
M. Pharm - QA
Goa College of Pharmacy
Panaji, GoaB. Pharm -
Goa College of Pharmacy
Panaji, GoaHSSCE -
Vasantrao Dempo Higher secondary
Miramar, GoaSSCE -
L.D. Samant Memorial High school
Porvorim, GoaSkills
- Microsoft Office
- SAP Successfactors
- TrackWise
- Amplelogic Document management system
- Document control
- FDA licensing
- Training coordination
Personal Information
- Date of Birth: 28/02/1989
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Languages
- English
- Hindi
- Konkani
- Marathi
Timeline
Corporate QA
Indoco Remedies Limited
09.2023 - Current
Quality Assurance
Unichem Laboratories Ltd.
07.2015 - 10.2021
Quality Assurance
Indoco Remedies Ltd.
09.2012 - 07.2015
M. Pharm - QA
Goa College of Pharmacy
B. Pharm -
Goa College of Pharmacy
HSSCE -
Vasantrao Dempo Higher secondary
SSCE -
L.D. Samant Memorial High school