Development Quality Assurance Specialist

Ataşehir, İstanbul
Sürekli
Tam zamanlı

9 gün önce

Job Description Summary As Development Quality Assurance Specialist you will ensure compliance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) across Novartis entities within a country, focusing on patient safety, data integrity, and quality oversight in both pre- and post-market settings. In this role you will collaborate with Development, Medical Affairs, and Novartis Country Quality teams to support high-quality execution of research and patient-facing programs and implement the Novartis Quality Manual and Quality Management System to maintain strong regulatory alignment and operational excellence.Job DescriptionLocation: Ataşehir, Istanbul, Turkey #HybridNovartis is unable to offer relocation support for this role: please only apply if this location is accesible for you.Key Responsibilities:Monitor, collect, and report Quality KPIs to support timely and accurate management reviews.Assist in Health Authority inspections and internal audits by providing required documentation and information.Support the implementation and maintenance of the local Quality System in alignment with the Novartis Quality Manual.Manage GxP Quality Assurance processes including Change Control, Training Management, Escalation, and Risk Management.Ensure full compliance with GxP standards and Novartis Quality procedures across all quality-related activities.Track and ensure timely completion of CAPAs, escalating unresolved issues as needed.Review quality deliverables for compliance with SOPs and regulatory requirements, including third-party work and clinical materials.Prepare, release, and archive GxP documentation; support inspection readiness and compliance reviews.Essential Requirements:University degree in Life Sciences, Pharmacy or related field.3 years of experience in Clinical or Pharmacovigilance activities is preferred.Strong knowledge of GxP, CAPA, Risk Management, SOPs, and Quality Management Systems (QMS).Skilled in Audit Management, Change Control, Root Cause Analysis, and Health Authority interactions.Demonstrated agility, influencing skills, and ability to collaborate across boundaries.Technological proficiency and self-awareness in a regulated environment.Fluent in English and Turkish.Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.Skills Desired Agility, Audit Management, Business Partnering, Continued Learning, Health Authorities, Change Control, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Sop (Standard Operating Procedure), Technological Expertise

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