Takeda Pharmaceuticals
Data Systems QA and Compliance Leader
Takeda Pharmaceuticals, Lexington, Massachusetts, United States, 02173
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Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job Description
Takeda Development Center Americas, Inc. is seeking a Data Systems QA and Compliance Leader in Lexington, MA with the following requirements:Bachelor's degree in Pharmacy or related field plus 4 years of related experience.Prior experience must include:Perform analytical method development (HPLC, UPLC) using reversed phase chromatography (RP) in a regulated environment (GxP/GLP) using Agilent ChemStation and Waters Empower 2 and 3 Chromatography Data System (CDS) and drafting SOPs (procedures) thereof;Draft and execute Computerized Systems Validation (CSV) for analytical instruments (ICP-MS, DSC) and enterprise systems (Empower) in accordance with electronic records and electronic signatures regulations, including 21 CFR Part 11;Author site-wide Standard Operating Procedures (SOPs) for calibration, preventative maintenance, and operation of Agilent High Performance Liquid Chromatography (HPLC and UPLC) 1100/1260/1290 Systems using Waters Empower and Agilent Chemstation in regulated GLP environment;Develop analytical and enterprise systems qualification protocols under GAMP (Good Automated Manufacturing Practice), electronic records and electronic signatures principles (21 CFR Part 11 and Annex 11) in commercial GMP environment;Troubleshoot, root-cause analyze, and resolve issues with deviations and out-of-specification (OOS) analytical instruments and infrastructure, while communicating to multidisciplinary teams, in commercial GMP environment;Perform calibration and preventative maintenance on analytical instruments and laboratory computerized systems in Commercial cGMP;Draft responses to regulatory agencies' queries including observations/483s and action plans based on the state of the art and regulations in the field.Up to 20% domestic & international travel required for R&D quality functions and activities.Full time. $177,500 - $186,000 per year.Apply on-line at
https://jobs.takeda.com
and search for Req #R0132042.Locations
Lexington, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time
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Privacy Notice
and
Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job Description
Takeda Development Center Americas, Inc. is seeking a Data Systems QA and Compliance Leader in Lexington, MA with the following requirements:Bachelor's degree in Pharmacy or related field plus 4 years of related experience.Prior experience must include:Perform analytical method development (HPLC, UPLC) using reversed phase chromatography (RP) in a regulated environment (GxP/GLP) using Agilent ChemStation and Waters Empower 2 and 3 Chromatography Data System (CDS) and drafting SOPs (procedures) thereof;Draft and execute Computerized Systems Validation (CSV) for analytical instruments (ICP-MS, DSC) and enterprise systems (Empower) in accordance with electronic records and electronic signatures regulations, including 21 CFR Part 11;Author site-wide Standard Operating Procedures (SOPs) for calibration, preventative maintenance, and operation of Agilent High Performance Liquid Chromatography (HPLC and UPLC) 1100/1260/1290 Systems using Waters Empower and Agilent Chemstation in regulated GLP environment;Develop analytical and enterprise systems qualification protocols under GAMP (Good Automated Manufacturing Practice), electronic records and electronic signatures principles (21 CFR Part 11 and Annex 11) in commercial GMP environment;Troubleshoot, root-cause analyze, and resolve issues with deviations and out-of-specification (OOS) analytical instruments and infrastructure, while communicating to multidisciplinary teams, in commercial GMP environment;Perform calibration and preventative maintenance on analytical instruments and laboratory computerized systems in Commercial cGMP;Draft responses to regulatory agencies' queries including observations/483s and action plans based on the state of the art and regulations in the field.Up to 20% domestic & international travel required for R&D quality functions and activities.Full time. $177,500 - $186,000 per year.Apply on-line at
https://jobs.takeda.com
and search for Req #R0132042.Locations
Lexington, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time
#J-18808-Ljbffr