Ashmita Dash

About Ashmita Dash

I have 6+ years of experience in bio therapeutics pharma Industry, I wants to serve myself in life science field which benefits to society, notably in the health industry.The following responsibilities I have been holding through out my industrial experience-Ensure quality of activities conducted in the bioanalytical lab, complies with established SOPs, QMS system, regulatory guidance without deviating from established procedure-Reviewing of clinical trial protocol and laboratory manual to ensure studies being conducted as per the guideline M11 and ICH E6 (R2)- Checking of data accuracy and integrity, data compilation and report preparation as per ALCOA++ proofreads clinical and regulatory documents with language specific to therapeutic language-Responsible for quality compliance of GMP during manufacturing & testing of batches under development / GMP / clinical trials at AIC pilot plant -Review of analytical related documents test results, COAs & support in Batch release.Coordination with respective develop teams for Identifying the material requirements for cell bank activities, R&D lots, GMP lots etc. Review and approval stability protocols & reports-Preparation of lot summary protocols for batches to be subjected to CDL release.Review and approval of RM/PM/CPC specifications, testing procedures and co-ordinate vendor qualification activities-Handling, follow up and closure of change controls, deviations, CAPAs, OOS,QRA and OOLs- Review of critical clinical documents such as clinical protocol, lab manual, CSR, summary document, and related regulatory documents, etc-Document Management and verification of source data (Raw data) from computerized system as per 21 CFR.Document management like handling of OOS, CAPA, incident, change control, amendment, etc-Proofreading of clinical protocol and related source documents for grammar, typo check and format-Review of clinical data including tables and figures for accuracy-On time escalation of issues in case of any unforeseen event to mitigate compliance issue-Review of Watson LIMS generated sequence, worklist and concentration data. Fair idea of TFL review-Identify, track and resolve protocol deviations as per defined SOPs, Conduct regular review (routine review of raw data, for DB lock, Manifestation etc.)- Review of PerkinElmer electronic laboratory notebooks data-Basic understanding of Clinical Data Management-Facing Internal/External Audits and resolved the non-compliance in a timely manner.

Experience

1. Senior Associate Qa-international Affiliates

   Amgen

   Mar 2025 — Present · Hyderabad, IN

   Act as QA contact for product and distribution complaints, supporting various quality records including CAPA, change controls, and temperature excursions. Maintain and manage quality documentation for complaints, recalls, and returns per regulations. Support internal and external audits, ensuring compliance with GDP and GMP standards. Apply knowledge of regulatory guidelines like cGDP and cGMP for pharma and device products. Integrate risk management into supply chain strategies. Develop quality reports and KPIs to monitor compliance and performance. Lead process improvement initiatives and promote a culture of quality across teams.

Education

• Kendriya Vidyalaya

  Science , Central Board of Secondary Education

• Nirma University

  M.Sc biotechnology, Biotechnology

• St. Xavier's College, Ahmedabad

  Bachelor of Science, Biochemistry and Vocational biotechnology