B Vidya

Quality Assurance professional with 5+ years of experience in the pharmaceutical industry. Strong experience in Monitoring Deviation, OOS, OOT, Incident management, Change Control, CAPA, APQR, Stability studies, Batch Record review, Vendor questionnaires, and audit support. Well-versed with cGMP requirements and QA documentation.

Executive – Quality Assurance - JY Pharma Pvt. Ltd. - Raichur

(2021-02 - 2025-03)

• Preparation and Review of Standard operating procedures.
• Preparation of all products APQR's
• Documentation Control as per GDP.
• Issuance, Review and archival of BMR/BPR
• Monitoring of Change Controls, Deviation, OOT, OOS, Incidents and CAPA
• Filling Vendor Questionnaires from customers and reviewing VQ from suppliers/vendors.
• Ensuring stability studies are conducted for shelf-life determination
• Preparation of Stability study compliance Report
• Monitoring during product manufacturing to compliance GMP.
• Monitoring dispatch Activities.
• Issuing raw material, recovery solvents, packing materials, intermediate & API worksheets to QCD. Issuing monthly & daily calibration formats. Issuing inward registers & equipment log books to QC & PD departments.
• Reviewing Analytical data documents

Quality Assurance Trainee - SRC Laboratories Pvt. Ltd. - Raichur

(2019-06 - 2021-01)

• Supported QA documentation, GMP activities, batch record review, and laboratory data review under supervision.

M.Sc. - Palamuru University

B.Sc. - Palamuru University

Intermediate - Telangana State Board of Intermediate Education

SSC - Andhra Pradesh State Board of Secondary Education