Quality Engineer Job in Rxlogix Corporation
Quality Engineer
Rxlogix Corporation
4+ weeks ago
- Bengaluru, Bangalore Urban, Karnataka
- Not Disclosed
- Full-time
Job Summary
- Essential Duties & 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.
- Minimum Requirements:
- Quick learner with positive attitude
- 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.
- Preferred Qualifications:
- 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 biopharmaceutical industry.


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