Ancy Mary Thomas
Pennington,NJ
Summary
Competent Quality Assurance Specialist with 4 years of experience in oversight of Pharmaceutical excellence. Proven record of quality leadership in all facets of production, team performance and fulfillment or delivery. Strategic in planning, implementing and improving processes and standards which generate opportunities for sustainable company growth.
Collaborates with groups or work independently with minimal supervision. Proficient in MasterControl and CDMS
Overview
3
3
years of professional experience
Work History
Quality Specialist – Quality Assurance
GSK
King of Prussia, PA
10.2023 - 01.2024
- Implemented new methods for measuring process effectiveness and efficiency within the organization.
- Managed and controlled GSK’s confidential documents for Quality while ensuring compliance to Good Documentation Practices.
- Managed departmental spreadsheets and applications for GSK’s record maintenance and tracking systems and appropriately notified CBRE and Client management of any Quality and Compliance issues.
- Reviewed controlled documents for alignment with GSK policies and GDP, which includes analysis of Quality and compliance data - reviewed and endorsed Set up and Review forms documentation upon approval for Manufacturing and Operations as well as Instrument Service Group.
- Issued, tracked, reconciled and archived logbooks.
- Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
- Provided technical support to other departments on quality-related matters.
- Controlled the document management activities including preparation, routing for approvals and final approval of documents including SOPs, MOAs, COAs and associated forms.
- Helps to facilitate process improvement by engaging appropriate resources in issue identification and resolution.
- Analyzed quality assurance data to identify trends and develop and implement corrective action plans.
- Maintained records of test results, QC and QA activities, and related documents.
- Prepared reports to communicate results of quality inspection activities to management.
- Created inspection checklists and trained staff members in proper use of them.
QA-Documentation Specialist
Catalent Pharma Solutions
Philadelphia, PA
03.2023 - 10.2023
- Provided training & guidance to users & new hires on Catalent's Electronic Document Management System i.e., CDMS, Documentum and other Quality systems as assigned.
- Researched and analyzed departmental feedback to identify areas of improvement.
- Controlled the document management activities including draft preparation, upload, promotion, final review of any changes, routing for approval, and effectiveness of revision controlled documents (which include controlled e-forms, attachments, all departmental SOPs of Catalent, MOAs, COAs, Master Batch Records) in Catalent's Electronic Data Management System (CDMS). Responsible for final approval & making them effective for execution.
- Analyzed and designed documents to be circulated to departments for chain approval.
- Worked cross functionally with stakeholders, managers at all levels within Catalent and other departments including Operations, Quality Control, Supply Chain, Project Management, Production, Engineering and managed the communication between these departments to ascertain pertinent information relating to the contract orders, and inquiries related to document control processes and procedures.
- Issued, tracked, and reconciled controlled e-forms and attachments, batch records for production & packaging, Logbooks, change controls, protocols, and reports.
- Reviewed the content & maintained standard formatting of all departmental SOPs and GMP records of Catalent for quality & completeness while ensuring compliance with ALCOA principle.
- Evaluated Quality system procedures & document control activities to propose & develop ideas for improving the efficiency while ensuring compliance to GDP.
- Managed and reviewed departmental spreadsheets and applications for Catalent’s record maintenance and tracking systems.
QA-Document Control Associate
Quality Assurance Department
Newtown, PA
11.2020 - 02.2023
- Project Lead on organizing historic batch records using 5S principles, resulting a 27% increase in Document Control efficiency.
- Organized & maintained both electronic & hardcopy of Master documents, MOAs, COAs, calibration records, stability & validation protocols, reports as well as labels to ensure the easy issuance & retrieval whenever required.
- Automated data workflows during process & data life cycle using Master Control software.
- Issued controlled e-forms, batch records for execution, change controls, protocols, reports and organized on secure server.
- Managed projects related to the implementation of new software programs related to document control.
- Reviewed documents and updated document management systems with new revisions or any changes in existing records.
- Processed incoming documentation requests from internal departments and external customers while maintaining cGMP compliance efficiently
- Performed quality assurance checks on all documents prior to distribution or archival storage.
- Supported new process implementations by developing Business process Workflow Diagrams.
- Reviewed & maintained standard formatting of all departmental SOPs and GMP data for quality & completeness while maintaining compliance with ALCOA+ principle.
Education
Bachelor of Engineering Technology - Information Technology
PRIST University
Tamil Nadu08-2020
Skills
Key-Skills
HTML, CSS, MySQL, JavaScript,
MS OFFICE– WORD, ADVANCED EXCEL, POWERPOINT, MS OUTLOOK,
ACCESS, VISIO, Project Management,
Data Analysis, Master Control, SAP,
SYSPRO, CRM, Documentum: CDMS, DocViewer, Compliance Wire, Veeva VQMS, EAM, CMX
Other Skills: Computer Proficiency, Technical, Marketing, Presentation, Multi-Tasking, Cross-Functional, Communication, Leadership, Quick Learner, Management Dashboards, Multitasking, Problem Solving abilities, Pivot Table, VLOOKUP, XLOOKUP, Power Query, Jira
Programming Knowledge: Python, C, C, Java, SQL
References
References available upon request.
Timeline
Quality Specialist – Quality Assurance
GSK
10.2023 - 01.2024
QA-Documentation Specialist
Catalent Pharma Solutions
03.2023 - 10.2023
QA-Document Control Associate
Quality Assurance Department
11.2020 - 02.2023
Bachelor of Engineering Technology - Information Technology
PRIST University
Similar Profiles
Clotilde JoretClotilde Joret
Human Resources Business Partner at GSKHuman Resources Business Partner at GSK
Junior CrawfordJunior Crawford
Growth Emerging Markets (GEM) Commercial Operations Senior Director at GSKGrowth Emerging Markets (GEM) Commercial Operations Senior Director at GSK
RAHUL PANDEYRAHUL PANDEY
Area Business Manager at GSKArea Business Manager at GSK
Helena MangualHelena Mangual
Senior Biopharmaceutical Associate at GSKSenior Biopharmaceutical Associate at GSK
Alex BerezAlex Berez
Assistant Athletic Director at Camp Greylock for BoysAssistant Athletic Director at Camp Greylock for Boys