Principal Engineer – IT QA & CSV

Summary

RxLogix is an innovative company developing cutting edge software products for the pharmaceutical industry. We are seeking passionate candidates to join our QA team in Noida, India.  We offer competitive salaries, and other benefits to make sure everyone here has a stake in our success.

We're a fast-growing organization looking for talented people to take on big, ambitious projects and deliver amazing results. 

Description

Note: This opportunity is not a fit for the software testing professionals. The candidate must possess experience in the Pharmaceutical IT Compliance areas/CSV.

1. Provide application validation expertise on GxP products for drug safety space.
2. Be accountable for reviewing and supporting key CSV deliverables - URS, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report and Validation Summary Reports.
3. Requirements Analysis and Risk Assessment, Profiling and Mitigation in collaboration with the SME.
4. Reviewing of the Qualification scripts (IQ, OQ, PQ scripts, results and reports) deliverables for Software categories.
5. Should have adequate understanding on Change Control Procedure, Deviation Handling, Document Management and CAPA management.
6. Closely work with clients and product owners to support implementation and resolve product quality issues.

Must Have Qualifications

1. BE/ B.Tech./ MCA/ B.Pharma/ M.Pharma from recognized institute with good academic score
2. IT Quality Assurance professional with 6 years of hands-on experience with computerized system validation in life sciences industry
3. Pharmaceutical/Life Sciences/ Medical Devices background
4. Understanding of risk-based system validation approach
5. Review of SDLC product documents from content perspective
6. End to end understanding of regulatory guidelines and required documentation for new system release
7. Regulatory/ client audit experience on IT systems
8. Worked in evolving the IT-QMS and possesses SOP/Template authoring experience
9. Guide the product/project team on the CSV impact for all the change controls
10. Knowledge of GxP, QA best practices
11. In depth understanding of the regulatory guidelines for IT systems– primarily FDA, EMA, MHRA and PMDA
12. In depth understanding of 21 CFR Part 11, EU Annex 11 compliance
13. In depth understanding of the implementation methodology for GxP system in accordance to CSV compliant model
14. Experienced in Documentation authoring, reviewing and requirement analysis
15. Should have extensive reviewing experience on the CSV documentation – CR, VP, URS, TP/QP, CSD, TSR, VSR, RTM 
16. Well-organized and detailed oriented professional, with strong verbal and written communication skills
17. Must be self- motivated with ability to handle, organize and prioritize multiple tasks
18. Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner
19. Should be able to achieve the optimum balance for Quality v/s Productivity
20. Experience in client interaction and client handling

Desirable Qualifications

1. Exposure to pharmacovigilance domain and drug safety applications – Argus or ArisG/J – strong preference
2. Experience with electronic document management system is a plus.
3. Experience with training coordination and management.
4. Worked in Agile / Scrum team structure
5. Experience in SQL and PLSQL writing

Duties and Responsibilities:

1. Reviewing the CSV documentation - VP, URS, Test Plan, CSD, IQ, OQ, PQ, TSR, VSR, RTM for RxLogix products and projects in PV domain
2. Organize and ensure accurate and reliable filing for the paper-based GxP documents
3. Assist in Quality Investigations and CAPAs
4. Support Internal and Client audits on IT-QMS and IT Products
5. Provide first level of guidance and support to the project teams on CSV approach required for a planned change to a GxP system
6. Participates in internal product audits and supporting external audits.
7. Processes and provides timely and accurate update on the assigned duties to the reporting manager.
8. Participates in the revision, review, and approval of SOPs and controlled templates.