QA Lead Validation GCP

2 weeks ago

Hyderabad, Telangana, India Makro Full time
QA Lead Validation (GCP) RoleOverview:
Responsiblefor the development implementation and effectiveness of qualitystrategies programs and functions for all products and technicalsolutions to meet all corporate and regulatory objectives withrespect to quality initiatives.Summary:Plans coordinates and directs activities concerned with MakroCare& DDi GCP Audits QMS Quality manual compliancerelatedactivities (ICH 21 CFR GPDR etc) SOP management and regulatorycompliance of processes and products.Plansand coordinates the quality management program designed to ensurequality development of products consistent with establishedstandards.Accountabilities:
  • Interfaceswith customers and vendors representing the company as Qualitychampion.
  • Formulates and maintains qualityassurance objectives complementary to corporate policies andgoals.
  • Support mock preapproval inspections(PAIs) and HA inspections as needed. Proactively research local andglobal initiatives trends and events that impact the maintenance ofcompliance. Mentor GCP/PV staff as required. Complete any otherrequest from global GCP Audit. Review and approve audit reports asrequired and also participate in the Lead Auditorprogram.
  • Ensure appropriate escalation toresponsible management in case of critical audit findings andsupport immediate followup measures according to the Novartisrequirements on Management Escalations and other relevantprocedures. Assess the adequacy of responses (CAPA plans) to auditfindings in cooperation with the Followup Responsible Person (FURP)and Quality Responsible Person(QARP).
  • Knowledge of ICHGCP guidelines andability to review and evaluate medicaldata
  • Designs and implements quality assurancetraining programs to key personnel in conjunction withmanagers.
  • Prepares and maintains control plansand revises/audits processes responds to customers qualityconcerns.
  • Manage client and regulatoryauthority audits
  • Maintains companywide QualityManagement System and ISOand ISO 14155 compliance. Oversee and ownSOPs for an entire organization
  • Author orReview validation documentation (plans protocols test suitesreports etc.).
  • Contributes to projectdiscoveries project kickoffs review proposals and statements ofwork to ensure CSV standards arerepresented.
  • Coordinates clientspecificvalidation activities with practiceleads.
  • Enforce QA requirements for IT qualitysystems with potential GxP impact.
  • Support GxPdecisions/strategies during validationprojects.
  • Document applicable deviations anddocumentation anomalies for computer systems undergoingvalidation.
  • Provides leadership throughout thelifecycle of a project guiding the understanding of the validationprocess that the project team has through design development andimplementation to ensure project requirements aremet.
  • Review requirements traceability matricestest suites and test executions.
  • Travelinvolved. Other duties as assigned.

KRAspread:
  • GCP Audits QAQMS and Corporate Quality Management:60%
  • Validation:40%

gcp,validation,gxp,compliance,documentation

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