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Quality Assurance Specialist

3+ years
Not Disclosed
10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Quality Assurance Specialist

Location: Istanbul Ataşehir, Turkey
Employment Type: Full-time
Job Requisition ID: REQ-10038364


Role Summary:

The Quality Assurance (QA) Specialist is responsible for managing quality aspects and projects within their area of responsibility. This role ensures GxP compliance and alignment with Novartis Quality Management Systems (QMS) while supporting key quality assurance processes such as batch release, deviation investigations, CAPA management, and regulatory compliance.


Key Responsibilities:

Quality System Implementation & Compliance:

  • Implement and maintain a local quality system in compliance with regulatory requirements and Novartis corporate quality policies.
  • Ensure ISO 9001:2015 Quality Management System implementation within the Country Organization.
  • Support GMP audits by Health Authorities, Novartis Global Functions, and third-party companies.

Batch Release & Quality Oversight:

  • Perform batch release checks and approvals for pharmaceutical products.
  • Coordinate with cross-functional teams responsible for GxP and health-regulated activities to ensure operational efficiency.
  • Manage product destruction processes from a quality perspective.

Deviation & Incident Management:

  • Lead quality incidents, deviations, and complaints evaluation and investigations.
  • Ensure appropriate Corrective and Preventive Actions (CAPAs) are implemented.

Documentation & Change Management:

  • Act as key user for ESOPs (SOP Tool) and Condor (Document Management Tool).
  • Prepare and maintain Standard Operating Procedures (SOPs).
  • Manage all changes affecting product quality.

Training & Reporting:

  • Manage GxP training activities for relevant functions.
  • Monitor and report Key Quality Indicators (KQIs) monthly, ensuring timely gap resolution.
  • Prepare quarterly/yearly quality review reports.

Requirements:

Education & Experience:

  • Bachelor’s degree in Pharmacy, Chemical Engineering, or Chemistry.
  • Minimum 3 years of experience in a Quality Assurance (QA) department.
  • Experience in Manufacturing, Quality Control, Validation, or Warehousing is advantageous.

Skills & Competencies:

  • Strong knowledge of cGMP regulations and Quality Management Systems (QMS).
  • Ability to multitask and meet deadlines.
  • Strong communication skills in English and Turkish.
  • Negotiation skills and ability to manage complex quality processes.
  • Curiosity, resilience, and continuous learning mindset.

Why Join Novartis?

At Novartis, our mission is to reimagine medicine to improve and extend lives. We offer a diverse and inclusive work environment with opportunities for personal and professional growth.

Learn more about our culture: Novartis Life Handbook

Join us and be part of a team making a real impact in healthcare!


How to Apply:

Interested candidates can apply through Novartis' official career portal.

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