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Principal Engineer – IT QA & CSV

RxLogix Corporation -
Noida, Uttar Pradesh

Quick apply

Job details

Full-time

Qualifications

Quality management
B.Pharma
Master's degree
SQL
MCA
Quality assurance
Bachelor's degree
M.Pharma
Scrum
Software testing
Agile
B.E.
PL/SQL
Document management systems
Communication skills
FDA regulations
SDLC

Full job description

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.

Provide application validation expertise on GxP products for drug safety space.

Be accountable for reviewing and supporting key CSV deliverables - URS, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report and Validation Summary Reports.

Requirements Analysis and Risk Assessment, Profiling and Mitigation in collaboration with the SME.

Reviewing of the Qualification scripts (IQ, OQ, PQ scripts, results and reports) deliverables for Software categories.

Should have adequate understanding on Change Control Procedure, Deviation Handling, Document Management and CAPA management.

Closely work with clients and product owners to support implementation and resolve product quality issues.

Must Have Qualifications

BE/ B.Tech./ MCA/ B.Pharma/ M.Pharma from recognized institute with good academic score

IT Quality Assurance professional with 6 years of hands-on experience with computerized system validation in life sciences industry

Pharmaceutical/Life Sciences/ Medical Devices background

Understanding of risk-based system validation approach

Review of SDLC product documents from content perspective

End to end understanding of regulatory guidelines and required documentation for new system release

Regulatory/ client audit experience on IT systems

Worked in evolving the IT-QMS and possesses SOP/Template authoring experience

Guide the product/project team on the CSV impact for all the change controls

Knowledge of GxP, QA best practices

In depth understanding of the regulatory guidelines for IT systems– primarily FDA, EMA, MHRA and PMDA

In depth understanding of 21 CFR Part 11, EU Annex 11 compliance

In depth understanding of the implementation methodology for GxP system in accordance to CSV compliant model

Experienced in Documentation authoring, reviewing and requirement analysis

Should have extensive reviewing experience on the CSV documentation – CR, VP, URS, TP/QP, CSD, TSR, VSR, RTM

Well-organized and detailed oriented professional, with strong verbal and written communication skills

Must be self- motivated with ability to handle, organize and prioritize multiple tasks

Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner

Should be able to achieve the optimum balance for Quality v/s Productivity

Experience in client interaction and client handling

Desirable Qualifications

Exposure to pharmacovigilance domain and drug safety applications – Argus or ArisG/J – strong preference

Experience with electronic document management system is a plus.

Experience with training coordination and management.

Worked in Agile / Scrum team structure

Experience in SQL and PLSQL writing

Duties and Responsibilities:

Reviewing the CSV documentation - VP, URS, Test Plan, CSD, IQ, OQ, PQ, TSR, VSR, RTM for RxLogix products and projects in PV domain

Organize and ensure accurate and reliable filing for the paper-based GxP documents

Assist in Quality Investigations and CAPAs

Support Internal and Client audits on IT-QMS and IT Products

Provide first level of guidance and support to the project teams on CSV approach required for a planned change to a GxP system

Participates in internal product audits and supporting external audits.

Processes and provides timely and accurate update on the assigned duties to the reporting manager.

Participates in the revision, review, and approval of SOPs and controlled templates.

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