Associate Director Quality Assurance

2 months ago


noida, India Le Human Resources Solutions Pvt. Ltd. Full time

Position: Associate Director Quality

Experience: 15to 20 Years

Location: Noida


INTERNAL AUDITS

▪ Perform in-depth Internal Audits

ISO standards:

• Product Management

• Software Development

• Regulatory adequacy

• Verification and Validation

• CSV Deliverables

• Information Security

• Incident Management

• Cloud Services on AWS

• Root Cause Analysis

▪ Audits to be technical and verify the documentation adequacy.

▪ Sampling of 25% of artefacts.

▪ Provide Audit reports and aid in remedial actions.

▪ Monthly audits of key divisions.

▪ Ensure smooth conduct of internal audits and timely addressal of internal commitments.


REVIEW OF CSV DELIVERABLES

▪ Reviewing key CSV deliverables – URS, Validation Plan, Test Plan, Traceability Matrix, Change Management, Impact Assessment, Configuration Management, Test Summary Report and Validation Summary Reports from Technical Adequacy.

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


CAPA PROCESS REVIEWS

▪ Reviewing adequacy of RCA and CAPA management in both CAPA forms and JIRA tickets (ENGJIRA and MSJIRA).

▪ Support in recalibration of RCAs to align to the right Root Cause, documentation of Correction, CA and PA.


Job Description:


SAMPLING OF TICKET ADEQUACY

▪ Reviewing adequacy of all incidents ENGJIRA and MSJIRA, for adequacy of documentation in varying fields.

▪ BE/ B.Tech./ MCA/M. Pharma or equivalent course from recognized institute with good academic score

▪ Assign well qualified staff, with a min of 15-20 years of experience having good exposure in Software Development, Product Implementation, CSV

▪ Good understanding of GxP, 21 CFR Part 11, EU Annex 11, ALCOA + principles, GDPR and any other applicable GxP regulations

▪ A minimum of Lead Auditor certification on ISO 9001:2015 and ISO 27001:2013.

▪ Experienced in Documentation authoring, reviewing and requirement analysis


Interested candidates can share resume on



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