Vidya Rane

A professional, with over 14 years of experience across handling (vendor) and compliance, handling electronic systems like DMS (for review and approval of documents), QAMS (for handling of change control, deviations, market complaint, OOS), LIMS (for batch release), PAS-X (for execution of eBMR) etc. Seeking a suitable position in Quality Assurance department of your organization where I can contribute my intelligence, knowledge, skills and dedication towards the growth of the organization and profession.

Sr. Executive in Quality Assurance - Reliance Life Sciences - Rabale, Navi Mumbai

(2024-10-07)

• Prepare, review, issue, retrieve, and manage SOPs, Batch Records, Site Master Files (SMF), and quality documents through DMS.
• Review and release of in process and finished product batches in LIMS.
• Submission of Annual Notifications of all products to Regulatory Affairs.
• Review and closure of BMR's & BPR's in PAS-X.
• Preparation and review of Annual Product Quality Review (APQR).
• LIMS intimation of stability batches and approval of stability protocols.
• Co-ordination with production, QC, stores, engineering of facility to improve quality systems to ensure smooth manufacturing of products.
• Documentation and Data control.
• Providing training to team and cross functional group on SOP's and GMP topics.

Executive in Advance Characterization Laboratory - Encube Ethicals Private Ltd - Mumbai Andheri (Marol)

(2020-10-27 - 2024-09-27)

• Handled internal quality audit. Prepared and presented audit reports that reflect audits results and document process. (Compliance Reports)
• Prepared MDR, protocols and reports for Extractable and Leachables.
• Prepared URS, IQ/OQ and PQ documents.
• Handled tracking and closure of Change Control through trackwise software.
• Performed and tracked QMS activities (CAPA, Deviations).
• Reviewed and monitored Instruments/Equipment's calibration, Preventive Maintenance, Validation, periodic Audit Trial and periodic back up as per schedule.
• Handled GDP, GLP activities.

Research Associate in Corporate quality assurance department - Macleods Pharmaceuticals Ltd. - Andheri

(2018-02-05 - 2020-10-26)

• Prepared Specifications and Standard Test Procedures for APIs and Excipients covering US, EU, and Domestic markets.
• Supported Dermal, Hormonal, and Solid Dosage product portfolios.
• Coordinated with Analytical Development, Formulation Development, Regulatory Affairs, and Procurement departments.
• Managed Change Control activities through TrackWise software.

Research Associate in ADL department - Ajanta Pharma Limited - Kandivali

(2015-12 - 2017-03)

• Performed analysis of formulation development samples using HPLC, UV Spectrophotometer, and Dissolution Apparatus.
• Conducted calibration of HPLC, Dissolution Apparatus, UV Spectrophotometer, pH Meter, and Balances.
• Performed analytical and stability studies for DCGI products.

QC chemist - Milan Laboratory Pvt. Ltd. - Kalamboli (Panvel)

(2012-04 - 2014-12)

• Conducted stability testing of finished pharmaceutical products using HPLC, UV Spectrophotometer, and Dissolution Apparatus.
• Performed instrument calibration and maintenance.
• Managed documentation and record keeping.

Msc. - Chemistry - Madurai University (2011)

Bsc. - Chemistry - Changu Kana Thakur college, Panvel (2009)

H.S.C - Maharashtra board (2006)

S.S.C - Maharashtra board (2004)