Quality Engineer

RxLogix Corporation; Dadri; On-site; INR 800,000 - 1,100,000; Full time

Job summary

RxLogix Corporation seeks a QA/QMS professional to maintain the Quality Management System documentation and support process changes within a bio-pharma setting. You will coordinate with heads of functions to update templates and deliver training on processes.

Responsibilities include driving non-conformance closures from audits, reviewing qualification scripts, and ensuring robust documentation practices under GxP guidelines.

Qualifications

• GxP and QA best practices knowledge required.
• Experience in documenting processes, templates and changes.
• 4+ years in document control in bio-pharma industry.

Responsibilities

• Maintain and improve the QMS. Coordinate process changes with function heads.
• Roll out trainings related to processes and templates.
• Track and close non-conformances from process audits and ensure closures.

Skills

GxP knowledge

QA best practices

Regulatory guidelines

Documentation authoring

Requirement analysis

Process engineering

Organization & communication

Education

BE/B.Tech/MCA

Tools

Electronic Document Management System

Job description

Job Status:

Full Time

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. Additional 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 bio pharmaceutical industry.