Aequor Information Technologies Pvt. Ltd.
Quality Assurance Compliance Specialist
Aequor Information Technologies Pvt. Ltd., Indianapolis, Indiana, us, 46262
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Hiring for Leading Pharmaceuticals/Medical Devices clients Job Title:
Senior QA Compliance Specialist (Shift hours 8-5)
Work Location:
Onsite Indianapolis, IN
Duration:
6 months
Purpose
The QA Compliance Specialist implements robust Quality Systems for RLT Indianapolis site considering Novartis 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, training and in the execution of health authority inspections.
Major Accountabilities
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 Novartis Corporate Inspections and Global Health Authority Inspections.
Facilitates training on all 3 programs.
Supports management to implement and maintain the following programs; Training and Qualification, Quality Management Review (KPIs), Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Novartis 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.
Required 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.
Digital & Technology Savvy
Operational Excellence
Breakthrough Analysis
Interpersonal Savvy
Organizational Savvy
Technical / Function Skills & Knowledge
As stated above.
Key Performance Indicators (KPIs)
Refer to annual performance target setting.
Education & Qualification B.S. degree, preferably in Life Sciences, chemistry or related relevant degree.
Seniority Level Mid-Senior level
Employment Type Contract
Job Function Quality Assurance, Manufacturing, and Training
Industries Pharmaceutical Manufacturing
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Hiring for Leading Pharmaceuticals/Medical Devices clients Job Title:
Senior QA Compliance Specialist (Shift hours 8-5)
Work Location:
Onsite Indianapolis, IN
Duration:
6 months
Purpose
The QA Compliance Specialist implements robust Quality Systems for RLT Indianapolis site considering Novartis 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, training and in the execution of health authority inspections.
Major Accountabilities
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 Novartis Corporate Inspections and Global Health Authority Inspections.
Facilitates training on all 3 programs.
Supports management to implement and maintain the following programs; Training and Qualification, Quality Management Review (KPIs), Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Novartis 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.
Required 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.
Digital & Technology Savvy
Operational Excellence
Breakthrough Analysis
Interpersonal Savvy
Organizational Savvy
Technical / Function Skills & Knowledge
As stated above.
Key Performance Indicators (KPIs)
Refer to annual performance target setting.
Education & Qualification B.S. degree, preferably in Life Sciences, chemistry or related relevant degree.
Seniority Level Mid-Senior level
Employment Type Contract
Job Function Quality Assurance, Manufacturing, and Training
Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Aequor Information Technologies Pvt. Ltd. by 2x
Get notified about new Quality Assurance Compliance Specialist jobs in
Indianapolis, IN .
#J-18808-Ljbffr