Mansi Mohan

Bachelor of Pharmacy graduate and Quality Assurance professional with progressive experience across pharmaceutical manufacturing environments, currently serving as Executive – Quality Assurance at Sunways Biosciences LLP. Skilled in managing core QMS elements including Deviation, CAPA, OOS, OOT, and Change Control, batch record review and validation activities, and documentation control encompassing MSDS, COA, and ADC clearance. Experienced in internal audits, regulatory guideline compliance, and risk assessment, with a track record of building QA fundamentals from the ground up through trainee, executive, and QA & RA roles at reputed pharmaceutical organizations along with product development including designing and labelling of the products.

Executive – Quality Assurance - Sunways Biosciences LLP - Gurugram, Haryana

(2026-01)

• Manage core QMS activities including deviation handling, CAPA, OOS/OOT support, and change control documentation.
• Review batch records and support validation activities to ensure compliance with approved protocols and SOPs.
• Prepare and review quality documentation including MSDS, COA, and ADC clearance records.
• Coordinate with production and warehouse teams to ensure timely closure of quality documentation and release activities.
• Coordination in Brand Registrations and maintaining track.
• Responsible for reviewing all the designing artwork for domestic and export as per Schedule M and respective guidelines of the products.
• Responsible for Barcode generation on GS1 software for product launch.
• Responsible for compiling all the documents and dossiers for export and domestic.
• Conducted literature review of pharmaceutical guidelines and veterinary products to support quality and regulatory compliance

Executive – QA & RA - All Cure Pharma Private Limited - Bahadurgarh, Haryana

(2024-11 - 2025-12)

• Managed QMS elements including deviation, CAPA, OOS, OOT, and change control in line with regulatory guidelines.
• Coordinated regulatory affairs activities including ADC clearance and supporting documentation.
• Participated in internal audits and compliance checks to verify adherence to applicable regulatory guidelines.
• Actively handled Vendor Qualifications.
• Authored Quality Policy, SMF, and VMP, creating a structured compliance framework for the facility
• Compiled NDA dossiers for submission to local FDA/CDSCO with zero major deficiencies noted
• Developed and implemented 40+ GMP-compliant SOPs for a new manufacturing site, supporting successful regulatory audits.

Trainee – QA - Akums Drugs & Pharmaceuticals Ltd. - Derabassi, Chandigarh

(2024-01 - 2024-11)

• Gained foundational exposure to QMS documentation, including basic deviation and change control record-keeping.
• Prepared quarterly trend analysis reports to support data-driven decision-making by senior management.
• Performed root cause investigations for 20+ OOS/OOT incidents, implementing CAPAs that reduced recurrence by 30%.

Bachelor of Pharmacy - Pharmacy - Techno India University (2024)

Intermediate - Sinha Modal High School (2018)

High School - Delhi Public School (2016)