Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Automation Compliance Specialist
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Support
Projektbeschreibung
Role - Automation Compliance Specialist
Location - Co. Carlow
Contract - Initially 4 months
Responsible for reviewing core site Automation Compliance aspects of cGMP for operational areas of Vaccine Sterile and Pharmaceutical Operations including site facilities, utilities, manufacturing, packaging, labelling, and laboratories.
Responsible for compliance review, assessments, and conformance to Manufacturing Standards, Quality Policies/Guidance for Automation System Life Cycle, and site procedures in accordance with government regulations as related to the qualification, maintenance, auditing, and retirement of automated systems.
Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.
Support and perform core activities associated with Automation that may include Qualification of Automation Systems, System Life Cycle Management, Business Systems Ownership, and Compliance Oversight.
Provide guidance and technical skill knowledge to site relating to scientific area and/or automation SLC and computer validation concepts. Guidance will be consistent with department, company, regulatory policies and practices.
Facilitate and/or provide guided training and internal consulting services incorporating current industry practices and governmental regulations pertinent to automation qualification, compliance oversight, quality systems business ownership, and SLC.
Perform compliance oversight assessments and support regulatory inspections related to automation. Participate in activities to ensure audit/inspection readiness.
Maintain project tracking systems and associated systems that support SLC automation efforts, Quality Systems, and Compliance Systems.
Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control.
Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
Location - Co. Carlow
Contract - Initially 4 months
Responsible for reviewing core site Automation Compliance aspects of cGMP for operational areas of Vaccine Sterile and Pharmaceutical Operations including site facilities, utilities, manufacturing, packaging, labelling, and laboratories.
Responsible for compliance review, assessments, and conformance to Manufacturing Standards, Quality Policies/Guidance for Automation System Life Cycle, and site procedures in accordance with government regulations as related to the qualification, maintenance, auditing, and retirement of automated systems.
Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.
Support and perform core activities associated with Automation that may include Qualification of Automation Systems, System Life Cycle Management, Business Systems Ownership, and Compliance Oversight.
Provide guidance and technical skill knowledge to site relating to scientific area and/or automation SLC and computer validation concepts. Guidance will be consistent with department, company, regulatory policies and practices.
Facilitate and/or provide guided training and internal consulting services incorporating current industry practices and governmental regulations pertinent to automation qualification, compliance oversight, quality systems business ownership, and SLC.
Perform compliance oversight assessments and support regulatory inspections related to automation. Participate in activities to ensure audit/inspection readiness.
Maintain project tracking systems and associated systems that support SLC automation efforts, Quality Systems, and Compliance Systems.
Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control.
Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Sonstiges