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Resume alert |
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Rockville, MD
... Project scope included existing custom software applications that had been in use for several years but not properly validated according to CAPA from FDA audit findings. • Experience with Legacy System -Data Migration. • Participated in an in-house ...
- Mar 08
Gaithersburg, MD
... Federal Regulatory Cybersecurity Examinations for Pharmaceutical Industries IT Desktop Security 2017 IT Quality Variance 2021- IT Deviation of CAPA Management 2021 IT Good Documentation Practices 2021 IT Document Management 2021 Product Integrity ...
- Feb 14
Falls Church, VA
... (September, 2007 - November, 2007) [Contract position] External Auditor (Pharmacovigilance / Drug Safety) After review of past 483’s, EIR’s and CAPA responses, performed a thorough external Audit in the areas of Pharmacovigilance that included ADR’s ...
- Jan 13
Rockville, MD
... Demonstrated ability to write protocols, documents, Standard Operating Procedures (SOP), Out of Specification (OOS), Deviations and Corrective and Preventive Actions (CAPA) in line with FDA regulations. Knowledgeable and follow Quality Management ...
- Jan 09
Capitol Heights, MD
... Guide engineers through difficult situations encountered during CAPA activities. Served as a facilitator for quality improvement teams, quality management training workshops, focus groups, or similar activities to promote improved quality systems ...
- 2023 Oct 21
Germantown, MD
... • Manage all aspects of the audit lifecycle: scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CAPA, and closing • Provide tactical direction of the auditing function, including ...
- 2023 Jul 30
Silver Spring, MD
... set-up standard cost for the respective PLs • Interacted with WW & Finance contacts globally daily • Maintained records of CAPA on monthly basis & prepared action plan for repeatable errors • KPI metrics reporting Production Lead – FAM Team- F&A ...
- 2023 Jun 06
Washington, DC
... Enforce and oversee all quality programs (Food Safety, GMP, PPE, Chemical, Suppliers, raw material, mock recalls, traceability etc.) Create and maintain CAPA, SCAR, RCA and microbial programs regarding Food Safety Maintain audit ready status; ...
- 2023 Jun 04
Washington, DC
... manage In-room dining service and menus, assisted service in the Spanish Steakhouse Capa; highly involve in the service at the Pool and Grill Bar expediting and managing food allergies. Creating customized menus for restricted allergies, along with ...
- 2021 Mar 08
Sterling, VA
... Environment: ISO 9001, CAPA, GCMS, Excel, SWOT, ABCI Guidance VOLUNTEER WORK Financial Management Association, CSULA January 2020 - Present President (2020-2021) Provide leadership & directions to the club - Maintain the regular contact and work ...
- 2021 Jan 09