| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLE PHONE NUMBER AVAILABLE LINKEDIN LINK AVAILABLECORE COMPETENCIESSeasoned Quality Professional with ten plus years of experience in pharmaceutical industry Working knowledge of QMS and GMP requirements Experience working with biopharmaceuticals and supply chains Additional experience as a licensed pharmacist Experience working at an electronic consumer products company Strong knowledge of 21 CFR 210/211, Part 11, Part 820, Part 110, Part 111, ICH Q7, ICH Q9, ISO 9001:2015, ISO 9000, PIC/S GMP Part 1, IPEC Excipient GMPEXPERIENCESQA ServicesSenior Quality Auditor Performed as needed on-site/remote supplier quality audits for various suppliers within the life sciences industry Conducted an initial supplier qualification of an aseptic manufacturing plant for an international pharmaceutical company in accordance to 21 CFR Part 210/211 Collaborated on a joint audit of a contract manufacturer of APIs in accordance to ISO 9001:2015 and 21 CFR Part 210/211 Led the audit of an excipient manufacturer according to ICH Q7 standards Durham, NC2023- PresentOpen Book ExtractsQuality Executive Ensured manufacturing areas are compliant with current guidance, industry standards and cGMP requirements and documentation has been completed to the 100% per Good Documentation Practices Participated in internal and external/ regulatory audits as required, reducing possible quality risks by 100% Reviewed all batch records, released all raw materials, signing off as final quality signatory while ensuring standardized testing on products, achieving 100% compliance Durham, NC2021- 2021IQVIASenior Consultant, Global Compliance Consulting Valuation of current processes, and recommendations of program enhancements to compliance analytics like Fair Market Value, Transparency data analytics and managed the policies and SOPs, methodologies, rate cards and tiering of Conducted auditing and monitoring in terms of plan development, live monitoring, transactional reviews and outsourced managed monitoring services Created high quality deliverables such as slide decks, process maps, charts, graphs and data visualizations that incorporate objectives, issues, insights, findings and recommendations Conducted interviews, working sessions, workshops, status updates, kickoff meetings with key stakeholders, SMEs Managed project management documentation, project objectives, project plans, identification of project tasks, analysis and synthesis of primary/ secondary research, trends, anomalies and outliers into executable strategiesNYC, NY2019 2020PricewaterhouseCoopers (PwC)Senior Associate, Intern, Pharmaceutical and Life Science Operations practice Active participant in quality/ regulatory project management associated with first time launch of a medical device by an electronic consumer products company Conducted interviews with stakeholders to understand internal processes and to propose relevant FDA compliant solutions Strategize market access insights for the novel medical device by interpreting market access information for future strategic initiatives and business decisions Boston, MA2018 2018GlaxoSmithKline (GSK)Supply Chain Quality Assurance Executive, Quality Assurance Pioneered project to merge supply chains within emerging markets of Cambodia, Laos, and Myanmar; maximized cost efficiencies and improve supplier relationship despite ambiguity in local practices Exceptional problem solving skills in leading an organizational continuous improvement process for supply chain quality management; outlined program objectives and KPIs Managed and collaborated with third party quality team (team of 5 personnel) in forecasting, warehousing, relabeling and distribution of medically critical pharmaceutical products thus preventing recall of products worth up to 1.8 million USD Singapore2016 2017YOURWAY TRANSPORT BIOPHARMAA global clinical trial materials company, Manager, Clinical Supply Chain Management and Quality Assurance Owner and administrator of supplier management system, approved supplier list (ASL) and supplier corrective action requests Performed initial and regular risk based audits for the qualification and maintenance of external vendors on ASL Collaborated with external vendors and internal departments to investigate and resolve quality issues like deviations, failures, complaints, and temperature excursions to prevent their reoccurrence Spearheaded all OOS investigations, deviations, change controls and CAPAs Presented quality metrics and any significant quality issues to senior management during regular quality councilsSingapore2013 2016MERCK & COConsultant, Medical Affairs Hired as an independent consultant to create a new training program for pharmaceuticals sales representatives for several pipeline assets Partnered closely with marketing, medical affairs, and commercial operations teams to develop and test salesforce training materials as per FDA regulation Collaborated closely with Medical Science Liaisons on the management of Key Opinion Leaders (KOLs) via the internal KOL Management System Singapore2013WATSONS PERSONAL HEALTHCAREPharmacistSingapore2010 2012EDUCATIONDUKE UNIVERSITY, The Fuqua School of BusinessMaster of Business Administration, Certificate in Health Sector Management Durham, NCMay 2019NATIONAL UNIVERSITY OF SINGAPOREBachelor of Science Degree, PharmacySingaporeJune 2010ADDITIONAL INFORMATIONPERMANENT US WORK AUTHORIZATIONVolunteer, Singapore Committee for United Nations Women, Project Inspire an initiative for social entrepreneurs to pitch funding for ideas to better womens welfare in Asia and the Pacific. Bilingual in English and Mandarin. Interests: running, Game of Thrones, cooking. |
