Saviance
Onsite role
Pay range: *** - *** based on qualifications
The QA Compliance Specialist implements robust Quality Systems for Indianapolis considering Client and regulatory requirements of the organization. This role contributes significantly to the execution of these systems, authors or contributes to the procedures governing these systems and works towards timely implementation, including experience in Quality Management Review, Self-Inspection and in the execution of health authority inspections. • Supports the development and oversight of robust quality systems, including both implementation and operation at site level. • Leads the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators, as appropriate. • Works with the management team to implement and execute the Inspection Readiness program; including Client Corporate Inspections and Global Health Authority Inspections. • Facilitates training on all QA Compliance programs. • Supports management to implement and maintain the following programs; Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Client Global document assessments required to be performed at the site level. • Contributes significantly to the site inspection preparation, program management, response and commitment process. • Escalates high quality risks per procedure and supports agency notifications such as Field Alerts. • Performs duties as assigned to ensure compliance to global and local regulations. • Represent QA Compliance on project teams and in meetings. • Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QS operations. • Adheres to all GMP requirements. • Other related duties as assigned.
Education & Qualification B.S. degree, preferably in Life Sciences, chemistry or related relevant degree.
Experiences 8+ years of experience in a GMP Biopharmaceutical environment 2+ years of experience in a Quality Assurance role • Experience reviewing systems and analyze data (paper or electronic) to identify specific compliance and data consistency issues. • Previous Quality Assurance experience required, including Data Integrity (ALCOA+) compliance. • Previous experience in QA Compliance including self-inspections, preferred. • Ability to apply a phase appropriate, risk-based approach to QA operational decisions. • Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System. • Working knowledge of cGMP/ICH/FDA/EU regulations and guidelines and experience in US and international regulatory agency inspections a plus. • Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint). • Strong follow-up and organizational skills. • Experience with radiopharmaceutical therapies a plus. • Direct experience reviewing and/or authoring standard operating procedures. • Ability to work well independently and within a team. • Excellent oral and written communication skills with technical writing experience required.
The QA Compliance Specialist implements robust Quality Systems for Indianapolis considering Client and regulatory requirements of the organization. This role contributes significantly to the execution of these systems, authors or contributes to the procedures governing these systems and works towards timely implementation, including experience in Quality Management Review, Self-Inspection and in the execution of health authority inspections. • Supports the development and oversight of robust quality systems, including both implementation and operation at site level. • Leads the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators, as appropriate. • Works with the management team to implement and execute the Inspection Readiness program; including Client Corporate Inspections and Global Health Authority Inspections. • Facilitates training on all QA Compliance programs. • Supports management to implement and maintain the following programs; Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Client Global document assessments required to be performed at the site level. • Contributes significantly to the site inspection preparation, program management, response and commitment process. • Escalates high quality risks per procedure and supports agency notifications such as Field Alerts. • Performs duties as assigned to ensure compliance to global and local regulations. • Represent QA Compliance on project teams and in meetings. • Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QS operations. • Adheres to all GMP requirements. • Other related duties as assigned.
Education & Qualification B.S. degree, preferably in Life Sciences, chemistry or related relevant degree.
Experiences 8+ years of experience in a GMP Biopharmaceutical environment 2+ years of experience in a Quality Assurance role • Experience reviewing systems and analyze data (paper or electronic) to identify specific compliance and data consistency issues. • Previous Quality Assurance experience required, including Data Integrity (ALCOA+) compliance. • Previous experience in QA Compliance including self-inspections, preferred. • Ability to apply a phase appropriate, risk-based approach to QA operational decisions. • Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System. • Working knowledge of cGMP/ICH/FDA/EU regulations and guidelines and experience in US and international regulatory agency inspections a plus. • Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint). • Strong follow-up and organizational skills. • Experience with radiopharmaceutical therapies a plus. • Direct experience reviewing and/or authoring standard operating procedures. • Ability to work well independently and within a team. • Excellent oral and written communication skills with technical writing experience required.