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North Babylon, NY
... ● Helped fill out Corrective Action Preventative Action (CAPA) items. ● Helped detect, find, and eliminate laboratory contamination issues. ● Streamlined and assisted in the implementation of a new sample tracking database on a laboratory-wide level ...
- Feb 05
Farmingdale, NY
... Initiating Deviations / CAPA and closing. Conducting Training sessions to respective team members. Handling of LIMS, QAMS & DMS software’s. Educational qualification: M.sc (organic chemistry) - from Osmania university during the period of 2009-2011 ...
- 2023 Jul 04
Fairfield, CT
... Device Designation (BDD) •ICH Guidance documents: ICH E3,5 & 6 •OSHA regulations •Software Validation / Part 11, CAPA, MDSAP, EU MDD to MDR transition Bloodborne Pathogens •Clinical Evaluation Reporting Experience Surgimed Solutions, LLC ...
- 2022 Dec 14
Brentwood, NY, 11717
... 1.7 Water Millenium, HP Chem Station, Varian Stars, Shimadzu Auditing (Process/Product) CAPA/OOS Investigations Organizational Training Organizational Change Management ISO 9001-2000 Certification Management FDA 111, 117, 210/211, 113/114 EU ...
- 2022 Dec 10
Babylon, NY
... Following-up and closing CAPA’S. Altaire Pharmaceuticals, Inc. Riverhead, NY 2009-2016 Quality Assurance Manager Promoted from Quality Assurance Supervisor to Quality Assurance Manager Implementing, developing and training a Quality Assurance ...
- 2022 Jan 12
Bridgeport, CT
... Skills: Six sigma, FMEA, Root cause analysis,5s, 5why, QMS, ISO 9001:2015, CAPA, GMP, JIT, Lean manufacturing. Certifications: Six Sigma Green Belt, Auto CAD, Marketing Master class. Area of proficiency: • Manufacturing System Design • Process ...
- 2021 Jan 30
Bay Shore, NY, 11706
... Organizations to confirm their required compliance with the FDA’s / ICH’s GLP, cGMP and GLP (GxP) regulations (including CAPA Program), 1.10 Development and maintenance of close association with Contract Research Organizations (CRO's) and Contract ...
- 2020 Nov 18
Ronkonkoma, NY
... Reviewer for BMR, BPR and ANDA validation documents, Handling Customer Complaints and raise CAPA, sampling of raw materials, Handling of Change control, deviation, APQR preparation and reviewer. Inprocess checks in packaging operation and ...
- 2020 Nov 08
Medford, NY
... equipment Prepared unscheduled maintenance work orders and SOP updates Participated in Corrective Action Preventive Action (CAPA) initiatives Analyzing and reporting of Statistical Process Control (SPC) data from production operation in real time ...
- 2020 Oct 13
Wantagh, NY
... Quality Assurance Quality Control Quality Management Risk Management Validation Audits Six-Sigma Waterfall Agile SDLC/PDLC Quality Center ServiceNow SharePoint SAP FDA FAA SOPs ITIL CFRs 21 CFR Part 11 FAR 117 ISO 9001 (2008 2015) CAPA RCA ...
- 2020 Sep 22