Associate director quality assurance
3 weeks ago
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 Gx P, 21 CFR Part 11, EU Annex 11, ALCOA + principles, GDPR and any other applicable Gx P 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 shruti@hrworksindia.com
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