Katalyst Healthcares & Life Sciences
Senior Quality Validation Lead
Katalyst Healthcares & Life Sciences, Boston, Massachusetts, us, 02298
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Senior Quality Validation Lead
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Senior Quality Validation Lead
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Katalyst CRO Understands regulations pertaining to the implementation and use of computerized systems in all GxP areas. Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5. Reviews and approves system lifecycle deliverables for new and modifications to computerized systems used in the GxP areas. Consults with QISM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity. Identifies and escalates areas of risk or non-compliance to manager / leadership team. Participates in performing Periodic Review activities of Computerized Systems. Provide support to regulatory inspection preparedness activities as needed. Experience performing Infrastructure Qualification activities.
Please make sure you read the following details carefully before making any applications.
Responsibilities
Understands regulations pertaining to the implementation and use of computerized systems in all GxP areas. Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5. Reviews and approves system lifecycle deliverables for new and modifications to computerized systems used in the GxP areas. Consults with QISM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity. Identifies and escalates areas of risk or non-compliance to manager / leadership team. Participates in performing Periodic Review activities of Computerized Systems. Provide support to regulatory inspection preparedness activities as needed. Experience performing Infrastructure Qualification activities.
Requirements:
Bachelor's degree and relevant GxP work experience. Proficiency in using Microsoft Office applications. 8-10 experience performing validation activities. Proficiency with regulations related to FDA / MHRA regulations. Use of computerized quality management systems. Experience with validation of Enterprise / Lab Computerized Systems. Quality metrics, dashboards, analysis and improvement programs. Knowledge of GAMP and Agile validation lifecycle and methodologies. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeContract Job function
Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Senior Quality Specialist jobs in
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Senior Quality Validation Lead
role at
Katalyst CRO Continue with Google Continue with Google Join to apply for the
Senior Quality Validation Lead
role at
Katalyst CRO Understands regulations pertaining to the implementation and use of computerized systems in all GxP areas. Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5. Reviews and approves system lifecycle deliverables for new and modifications to computerized systems used in the GxP areas. Consults with QISM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity. Identifies and escalates areas of risk or non-compliance to manager / leadership team. Participates in performing Periodic Review activities of Computerized Systems. Provide support to regulatory inspection preparedness activities as needed. Experience performing Infrastructure Qualification activities.
Please make sure you read the following details carefully before making any applications.
Responsibilities
Understands regulations pertaining to the implementation and use of computerized systems in all GxP areas. Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5. Reviews and approves system lifecycle deliverables for new and modifications to computerized systems used in the GxP areas. Consults with QISM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity. Identifies and escalates areas of risk or non-compliance to manager / leadership team. Participates in performing Periodic Review activities of Computerized Systems. Provide support to regulatory inspection preparedness activities as needed. Experience performing Infrastructure Qualification activities.
Requirements:
Bachelor's degree and relevant GxP work experience. Proficiency in using Microsoft Office applications. 8-10 experience performing validation activities. Proficiency with regulations related to FDA / MHRA regulations. Use of computerized quality management systems. Experience with validation of Enterprise / Lab Computerized Systems. Quality metrics, dashboards, analysis and improvement programs. Knowledge of GAMP and Agile validation lifecycle and methodologies. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeContract Job function
Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Senior Quality Specialist jobs in
Boston, MA . Senior Specialist, Pharmacovigilance Quality and Compliance Waltham, MA $112,000 - $154,000 6 days ago Lexington, MA $255,800 - $401,940 2 weeks ago Senior Quality Compliance Specialist - TrainingSenior Hardware Quality Engineer (Accessories) Lexington, MA $255,800.00 - $401,940.00 1 week ago Senior Quality Engineer, Post Market (Hybrid - Acton, MA.) Acton, MA $85,125.00 - $127,687.50 2 weeks ago Sr. Quality Engineer [Must Have Design Control]Sr. Quality Engineer (Must Have Exp @ MFG Facility with MFG Operations)MES Global Quality Champion - Fixed Term ContractClinical Quality Nurse - Dialysis/Vascular Access - 40 hours M-FDirector, Human Resources Business Partner, Commercial (Boston, MA)Nursing Quality and Patient Safety Fellow BWHSenior Quality Engineer (including machined parts) Acton, MA $89,000.00 - $101,000.00 1 day ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr