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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

Job Location: Istanbul Ataşehir

Employment Type: Full-time

Job Summary:

The Quality Assurance Specialist is responsible for managing quality aspects and projects within the designated area, ensuring compliance with Good Manufacturing Practices (GxP) and Novartis Quality Management Systems (QMS). The role involves coordinating with various functions to ensure adherence to regulatory requirements and maintaining an efficient local quality system.


Key Responsibilities:

Quality System Implementation & Compliance

  • Implement and maintain a local quality system that aligns with regulatory requirements and Novartis corporate quality policies.
  • Ensure compliance with GxP guidelines, ISO 9001:2015 standards, and other quality management system requirements.
  • Support internal and external quality audits conducted by health authorities, Novartis Global, or third-party organizations.

Batch Release & Product Quality

  • Support batch release activities, including quality checks and product approval.
  • Manage product destruction processes from a quality perspective.

Quality Deviations, Complaints & CAPA Management

  • Investigate quality deviations and customer complaints, ensuring effective corrective and preventive actions (CAPA) are implemented.
  • Lead the management of quality incidents and ensure resolution in line with company policies.
  • Oversee all change management activities affecting product quality.

Documentation & Training

  • Act as the key user for Electronic Standard Operating Procedures (ESOPs) and Condor Document Management System.
  • Prepare and update Standard Operating Procedures (SOPs) related to quality assurance.
  • Support and oversee training activities for GxP functions, ensuring compliance with regulatory and internal requirements.

Performance Monitoring & Reporting

  • Report and monitor Key Quality Indicators (KQIs) monthly and ensure corrective measures are implemented when needed.
  • Prepare yearly and quarterly review reports summarizing quality assurance activities.

Required Qualifications & Experience:

  • Education: Bachelor's degree in Pharmacy, Chemical Engineering, Chemistry, or a related field.
  • Experience: Minimum 3 years of experience in a Quality Assurance (QA) department within the pharmaceutical or life sciences industry.
  • Knowledge of cGMP regulations, CAPA management, and quality documentation practices.
  • Experience in Manufacturing, Quality Control, Validation, or Warehousing is an added advantage.
  • Strong communication skills in English and the local language.
  • Ability to multitask, handle complexity, and meet deadlines.

Desired Skills:

  • Quality Management & Regulatory Knowledge (ISO 9001:2015, GxP, cGMP).
  • Problem-solving and decision-making skills for managing CAPAs, deviations, and audits.
  • Strong documentation and technological expertise in QA tools and systems.
  • Analytical thinking, negotiation, and business insight for process improvements.
  • Resilience and adaptability to work in a dynamic quality environment.

Why Join Novartis?

Novartis is committed to reimagining medicine to improve lives globally. The company fosters an inclusive and diverse work environment that values innovation, continuous learning, and employee well-being.

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