Shreya Gandhi
Ashburn,USA
Summary
Certified Quality Auditor with extensive QA experience in a CGMP manufacturing setting. Specializes in on-the-floor QA support, batch record review, and release. Skilled in implementing Quality Systems for Deviations, Change Controls, CAPAs, and coordinating CRB processes. Proficient in creating and reviewing raw material specifications to meet regulatory requirements and quality standards. Experienced in validation processes, including reviewing and approving IQ/OQ/PQ/RQ protocols and final reports. Knowledgeable about large-scale protein purification processes and buffer manufacturing. Detail-oriented with exceptional investigation, problem-solving, and organizational skills. A quick learner who excels in fast-paced environments, demonstrating critical thinking abilities and the capacity to work independently to achieve objectives. Highly motivated and dedicated to delivering high-quality work within specified deadlines to meet operational demands.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Senior Specialist, Quality Systems
BIONTECH
03.2022 - Current
- Implement Quality Systems governance for Deviations, OOSs, CAPAs, Change Controls, and Internal Auditing, Support, develop and deliver technical and/or compliance training to BioNTech’s staff (including quality systems and E-Systems)
- Support Implementation and Validation testing of Veeva eQMS and Key User of Veeva eQMS at the Site.
- Leading and supporting Regulatory Surveillance program.
- Support Internal and QP Audit and Self inspections at the Site.
- Leading and Coordinating Change Review Board at the Site.
- Support tracking and communication of site metrics to management, including but not limited to Quality Management Review
- Review and approve procedures, which include, but are not limited to: Global SOPs for Quality Events, Local SOPs, controlled forms, and work instructions.
Senior Quality Assurance Specialist
SANARIA
01.2019 - 01.2022
- Reviewing and managing deviations, investigations, OOS and CAPA in Quality management system.
- Reviewing processed intermediates, Manufacturing batch records. Working on the lot release of the vaccine.
- Provided GDP training to new employees.
- Worked to improve the deviation management process to make it efficient and complaint.
- Author and Review the Sanaria’s Manufacturing, Quality Assurance, Cleaning SOP’s. Created and maintaining the supplier Qualification program and Internal Audit program.
Quality Assurance Specialist II
NOVAVAX
01.2016 - 01.2019
- Reviewed deviations, CAPA records, change control, and non-conformance records in quality management software system.
- Provided review and authored new or revised QA standard operating procedures (SOPs) Master Batch Records (MBRs), Raw material specifications and other controlled documentation. Interacted with functional groups, resolving discrepancies / observations discovered in real time or during lot review.
- Reviewed production batch documentation to support all disposition activities, including review of batch production records, logbooks, and support data, ensuring completeness, traceability, accuracy, and compliance to cGMP requirements.
- Compiled batch documentation for lot release, meeting and often exceeding release timelines. Maintained systems for organizing, tracking, and reporting batch disposition and review metrics.
Quality Assurance Specialist
ABL
01.2015 - 01.2016
- Reviewed client-provided documents to comply with ABL policies for product receipt, manufacturing, and shipment. Assisted validation management in performing final review of validation protocols, data, and summary reports.
- Provided expertise and troubleshooting for all in-house quality related concerns.
- Reviewed and approved SOPs, material, process, and product specifications related to cGMP activities. Supported packaging and labeling in performance of standard packaging operations.
- Followed written procedures and performed review of all records and associated data to release products manufactured by ABL, meeting product supply schedules, including completion of checklists, certificates of analysis, and conformance. Ensured accuracy and reliability of instrumental results of equipment maintenance and calibration program.
- Drove continuous improvements to ABL facility and quality systems by providing guidance and training to staff regarding cGMP compliance and reporting quality deficiencies to supervisors and department managers.
Quality Assurance Specialist (QA Purification Operations)
GENZYME CORPORATION
01.2011 - 01.2014
- Prepared release summary documentation files to submit to bulk release QA group for lot disposition.
- Provided floor support to manufacturing operations. Reviewed and approved completed batch record documentation, as well as supporting data, to release intermediate and final bulk product material.
- Dispositioned process intermediates, allowing for further downstream processing, including preparation of certificate of analysis (COA) and release labeling.
- Initiated Trackwise deviations and participated in root cause investigations, identifying appropriate corrective actions. Partnered with manufacturing, helping drive batch record review real first time (RFT). Worked closely with third-party quantic batch record reviewers, addressing observations and questions related to batch record review.
Clinical Pharmacist Intern
WOCKHARDT HOSPITAL
01.2008 - 01.2008
- Performed audits of drug supply records and ward rounds to provide patient counseling about drug interactions, potential side effects, and adverse drug reporting procedures.
- Dispensed drug material to hospital wards per direction of physicians. Participated in group discussions with physicians across different departments, expanding individual knowledge about patients and medicines.
Education
Master of Science (MS) - Regulatory Affairs of Drugs, Biologics, and Medical Devices
Northeastern University
Boston, MA01.2011
Bachelor of Pharmacy, (BPharm) - undefined
University of Mumbai
01.2009
Skills
- Deviations, Change controls and CAPA
- Veeva eQMS expert
- Facilitating change review processes
- Lot release documentation preparation
- Supplier qualification processes
- Effective team leadership
- Data analysis and problem-solving
- Proficient in cGMP compliance
- Understanding of ICH guidelines for drugs and devices
- Proficient in Windows and Microsoft Office applications
- Experienced with TrackWise, QUMAS, LIMS, ZenQMS
Certification
Quality Auditor Certification: ASQ-CQA
Timeline
Senior Specialist, Quality Systems
BIONTECH
03.2022 - Current
Senior Quality Assurance Specialist
SANARIA
01.2019 - 01.2022
Quality Assurance Specialist II
NOVAVAX
01.2016 - 01.2019
Quality Assurance Specialist
ABL
01.2015 - 01.2016
Quality Assurance Specialist (QA Purification Operations)
GENZYME CORPORATION
01.2011 - 01.2014
Clinical Pharmacist Intern
WOCKHARDT HOSPITAL
01.2008 - 01.2008
Bachelor of Pharmacy, (BPharm) - undefined
University of Mumbai
Master of Science (MS) - Regulatory Affairs of Drugs, Biologics, and Medical Devices
Northeastern University
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