Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners.
Key Responsibilities:
Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows
Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, etc.) to ensure appropriate execution of service deliverables
Generate and analyse predefined and ad-hoc reports in various applications (like AGILE PLM, AQWA etc.) and perform follow-up actions if required
Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures
Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements
Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes
Assist the department on any other ad hoc administrative activities as per business requirements.
Focus on timely completion of all relevant and assigned trainings
Learn & develop understanding to generate insights through data and digital
Ensure responsibility and ownership of the assigned tasks
Comply the accuracy and timeliness of deliverables
Essential Requirements:
Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute
Min 3 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices.
Perform APQR Master plan coordinator role & support for creation of draft annual plan and sharing it for approval & KQI reporting activities.
Acting as site owner for maintenance of SharePoint as requested by Business Partner
Responsible to update the information on SharePoint/ trackers, review the applicable documents for correctness and archival of necessary documents on SharePoint.
Provide Administrative support in preparation of Quality Management Review meeting slide deck & metrics reporting.
Maintenance of distribution lists and Active Directory Group Management.
Preparation, approval, and management of QAA & QAA tracker for clinical development (ESP QA).
Self-Inspection (SI) Planner role in AQWA-A. Creation of the child record for required target site based on the final SI approved plan for NCQ.
Author and approver role for metric reporting of QAA and QRA (ESO suppliers) in QADM tool.
Develop and maintain process SOPs, working procedures and process maps.
Act as QC admin support to perform incident /access review .
Provide support for GMP External Audits and inspection management activities (HA and Self Inspection Audits)
Maintain Approved supplier list for GxP vendors.
Ensure the completeness of KQI metrics as per requirement of compliance team.
Perform QARP role in AQWA-A for audit CAPA activities for audits of external suppliers/CMOs,
Preparation of UQAP (Unified Quality Audit Program), Audit preparation support and QARP (Quality assurance responsible Person) Role for audit CAPA Management.
Co-ordinating in process of assessment and implementation of Global Novartis Standards and procedural documents with wide applicability at Novartis Gene Therapies (GTx) and other applicable sites.
Manage creation of New Supplier Records, Maintenance/Update of Current Active Supplier and Monitoring Suppliers in ESPIR
