What are the responsibilities and job description for the QA Engineer (QAE) position at Lupin Ltd?
Shape the Future of Quality Systems and Compliance
Job Description
We are seeking an experienced Quality Engineer-CSV to support the administration, validation, maintenance, and continuous improvement of computerized and electronic Quality Systems across laboratory, manufacturing, and Quality operations.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
Search Firm Representatives Please Read Carefully
Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails
Competencies
Collaboration
Customer Centricity
Developing Talent
Innovation & Creativity
Process Excellence
Result Orientation
Stakeholder Management
Strategic Agility
Nearest Major Market: New Jersey
Shape the Future of Quality Systems and Compliance
Job Description
We are seeking an experienced Quality Engineer-CSV to support the administration, validation, maintenance, and continuous improvement of computerized and electronic Quality Systems across laboratory, manufacturing, and Quality operations.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
Search Firm Representatives Please Read Carefully
Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails
Competencies
Collaboration
Customer Centricity
Developing Talent
Innovation & Creativity
Process Excellence
Result Orientation
Stakeholder Management
Strategic Agility
Job Description
We are seeking an experienced Quality Engineer-CSV to support the administration, validation, maintenance, and continuous improvement of computerized and electronic Quality Systems across laboratory, manufacturing, and Quality operations.
- Administer and support PLCs, SCADA systems, Windows-based applications, laboratory instruments, manufacturing systems, and enterprise applications.
- Support system administration activities including user/role management, security configuration, audit trails, backup/restore, reporting, and other system configurations.
- Provide end-user and operational support for Veeva Vault QMS, QualityDocs, Vault Training, and other quality systems.
- Maintain and improve electronic Quality Systems, including workflows, configurations, procedures, and system processes.
- Develop and monitor Quality System metrics/KPIs, identify trends, and present results and improvement opportunities to management.
- Identify opportunities to simplify, standardize, and improve the efficiency of Quality and computerized system processes.
- Perform CSV and data integrity activities including risk assessments, URS, configuration specifications, testing/UAT, RTM, validation reports, periodic reviews, and SOP updates.
- Support qualification (Installation, Operational, and Performance Qualification) reviews of laboratory instruments and manufacturing equipment.
- Partner with Quality, IT, Engineering, vendors, and business users to troubleshoot issues and implement system enhancements.
- Ensure compliance with 21 CFR Part 11, 21 CFR Part 211, EU Annex 11, GAMP 5, Data Integrity.
- Strong knowledge of GAMP 5, Annex 11, CSV, data integrity, and applicable FDA/EU requirements.
- Experience with Veeva Vault or similar electronic Quality Systems preferred.
- Strong analytical, troubleshooting, communication, and stakeholder-management skills.
- Hands on knowledge on Veeva, LIMS, ELN, SAP, and MES systems is preferred
- 3-8 years of experience in Quality Systems, CSV, systems administration.
- Experience supporting laboratory, manufacturing, and/or enterprise computerized systems
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
Search Firm Representatives Please Read Carefully
Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails
Competencies
Collaboration
Customer Centricity
Developing Talent
Innovation & Creativity
Process Excellence
Result Orientation
Stakeholder Management
Strategic Agility
Nearest Major Market: New Jersey
Shape the Future of Quality Systems and Compliance
Job Description
We are seeking an experienced Quality Engineer-CSV to support the administration, validation, maintenance, and continuous improvement of computerized and electronic Quality Systems across laboratory, manufacturing, and Quality operations.
- Administer and support PLCs, SCADA systems, Windows-based applications, laboratory instruments, manufacturing systems, and enterprise applications.
- Support system administration activities including user/role management, security configuration, audit trails, backup/restore, reporting, and other system configurations.
- Provide end-user and operational support for Veeva Vault QMS, QualityDocs, Vault Training, and other quality systems.
- Maintain and improve electronic Quality Systems, including workflows, configurations, procedures, and system processes.
- Develop and monitor Quality System metrics/KPIs, identify trends, and present results and improvement opportunities to management.
- Identify opportunities to simplify, standardize, and improve the efficiency of Quality and computerized system processes.
- Perform CSV and data integrity activities including risk assessments, URS, configuration specifications, testing/UAT, RTM, validation reports, periodic reviews, and SOP updates.
- Support qualification (Installation, Operational, and Performance Qualification) reviews of laboratory instruments and manufacturing equipment.
- Partner with Quality, IT, Engineering, vendors, and business users to troubleshoot issues and implement system enhancements.
- Ensure compliance with 21 CFR Part 11, 21 CFR Part 211, EU Annex 11, GAMP 5, Data Integrity.
- Strong knowledge of GAMP 5, Annex 11, CSV, data integrity, and applicable FDA/EU requirements.
- Experience with Veeva Vault or similar electronic Quality Systems preferred.
- Strong analytical, troubleshooting, communication, and stakeholder-management skills.
- Hands on knowledge on Veeva, LIMS, ELN, SAP, and MES systems is preferred
- 3-8 years of experience in Quality Systems, CSV, systems administration.
- Experience supporting laboratory, manufacturing, and/or enterprise computerized systems
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
Search Firm Representatives Please Read Carefully
Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails
Competencies
Collaboration
Customer Centricity
Developing Talent
Innovation & Creativity
Process Excellence
Result Orientation
Stakeholder Management
Strategic Agility
Salary : $70,000 - $90,000