Vaishali Kulkarni
Assistant general manager, Corporate Quality Assurance at Rubicon Research Pvt Ltd
- Role
- Assistant General Manager, Corporate Quality Assurance at Rubicon Research Limited
- Location
- Thane, IN
- LinkedIn followers
- 500 followers
About Vaishali Kulkarni
About 21 years experienced Asst.General Manager with a demonstrated history of working in the pharmaceuticals industry. Currently working for corporate Quality and automation function. Has good exposure to Method Development and validation, experienced in handling quality control and assurance activities.Experience in conducting and facing audits. Experienced the regulatory audits like USFDA, MHRA multiple times. Cleaning Validation, and Abbreviated New Drug Application (ANDA). Strong pharma Analytical and quality professional with a PGDFDC,MSc focused in analytical chemistry from VJTI,MKU.
Experience
Assistant General Manager, Corporate Quality Assurance
Jun 2020 — Present · IN
My Job responsibility as AGM,CQA include- Providing necessary assistance and technical expertise to multiple sites of Rubicon group i.e. development & manufacturing sites of Rubicon in India & Canada and to project concerning matters of quality and operations-Working on projects for automation of manual systems for various sites of Rubicon & involve in CSV- Ensuring harmonization and integration of quality & operational systems across Rubicon sites- Setting up quality systems at new sites being acquired by Rubicon- Reviewing and providing guidance to units in SOP preparations and training- Take up Quality Assurance responsibility as unit QA for Rubicon units as an when required-Providing regular updates on quality matters to management through quality review meetings- Representing Quality team during audits at Rubicon sites & providing response to observations-Qualification of vendors for units across Rubicon sites-Addressing audit observations at any site and extending the system compliance across all Rubicon sites-Visiting Rubicon sites or contract manufacturing sites for short or long durations for setting up quality systems/ providing compliance / training & development/ audit purpose-
Education
VJTI,MKU
PGDFDC,MSc, analytical chemistry
1997 — 1999
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