Quality Engineer

RxLogix Corporation; Bengaluru; On-site; INR 600,000 - 1,000,000; Full time

Job summary

A leading pharmaceutical solutions company is seeking a Quality Engineer to support the upkeep of the Quality Management System (QMS). Responsibilities include coordinating updates to processes/templates, rolling out trainings, and following up on audit outcomes. The ideal candidate will have a BE/B.Tech/MCA, 4 years of experience in document control within the bio-pharmaceutical industry, and strong organizational and communication skills. This is an opportunity to contribute to quality assurance and compliance in a dynamic environment.

Qualifications

• 3+ years of experience in documentation authoring and requirement analysis.
• Ability to interpret business requirements to technical/application requirements.
• Experience in process engineering is desirable.
• Quality professional with hands-on experience in document control process.
• Can interpret business requirements to technical/ application requirements and vis-a versa.
• Experienced in Process engineering (desirable).
• Experience with electronic document management system is a plus.
• 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 and be able to perform under pressure to meet deadlines.
• Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.
• BE/B.Tech/MCA from recognized institute with good academic score.
• Quality professional with 4 years of hands-on experience with document control process in bio pharmaceutical industry.

Responsibilities

• Support the upkeep of the QMS.
• Coordinate process/template creation and updates.
• Roll out trainings regarding processes.
• Drive and close non-conformances from audits.
• Review and support key CSV deliverables.
• Participate in external audits/assessments.
• Be accountable for reviewing and supporting key CSV deliverables – URS, Validation Plan, Test Plan,
• Traceability Matrix, Test Summary Report and Validation Summary Reports.
• Reviewing of the Qualification scripts (IQ, OQ, PQ scripts, results and reports) deliverables for Software categories.
• Quick learner with positive attitude

Skills

Software engineering discipline

Knowledge of GxP, QA best practices

Documentation authoring

Requirement analysis

Process engineering

Electronic document management system

Strong verbal and written communication skills

Self-motivated

Ability to prioritize multiple tasks

Quality issue resolution

Education

BE/B.Tech/MCA from recognized institute

Job description

Overview

Application for Quality Engineer

Responsibilities

• The person would be responsible for supporting the upkeep of the QMS.
• Support in making changes to the QMS and working with function heads to coordinate process creation, template creations and updates to existing processes/templates.
• Support in rolling out Trainings with regard to Processes
• Drive, Track and close Non-Conformances raised across delivery groups as an outcome to process audits.
• Follow-ups on audit outcomes and support in necessary documentation and connecting with action owners to drive closures
• Coordinate and participate in the external audits/assessments.
• Be accountable for reviewing and supporting key CSV deliverables – URS, Validation Plan, Test Plan,
• Traceability Matrix, Test Summary Report and Validation Summary Reports.
• Reviewing of the Qualification scripts (IQ, OQ, PQ scripts, results and reports) deliverables for Software categories.
• Quick learner with positive attitude

Qualifications

• Software engineering discipline
• Knowledge of GxP, QA best practices and regulatory guidelines
• Experienced in Documentation authoring and requirement analysis (min. 3 years)
• Can interpret business requirements to technical/ application requirements and vis-a versa
• Experienced in Process engineering (desirable)
• Experience with electronic document management system is a plus.
• 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 and be able to perform under pressure to meet deadlines.
• Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.
• BE/B.Tech/MCA from recognized institute with good academic score.
• Quality professional with 4 years of hands-on experience with document control process in bio pharmaceutical industry.

Application details

*Only PDF or DOCX type files are allowed

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