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    Qa Ecompliance Expert/Specialist (D/F/M)

    Novartis
    3-5 years
    Not Disclosed
    Remote - Europe
    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: QA eCompliance Expert/Specialist (d/f/m)

    Location: Ljubljana or Lendava, Slovenia
    Employment Type: Full-time
    Job Requisition ID: REQ-10029462
    Application Deadline: February 10, 2025

    Role Overview:

    Join Sandoz as a QA eCompliance Expert/Specialist and become part of a dynamic Quality Assurance (QA) Compliance team dedicated to ensuring regulatory compliance and data integrity for GxP computerized systems.

    In this role, you will play a critical part in quality assurance by providing expertise in compliance auditing, risk management, inspection readiness, and regulatory compliance. Your work will directly contribute to delivering high-quality, accessible medicines to patients worldwide.

    This position offers exciting career growth opportunities, a flexible hybrid work model, and a collaborative work environment.

    Key Responsibilities:

    • Ensure compliance with cGxP (current Good x Practices) regulations, including data integrity.
    • Support audit and inspection processes, ensuring readiness and compliance.
    • Review and approve change control processes for GxP computerized systems.
    • Oversee local DI (Data Integrity) and eCompliance activities, including training, inspections, planning, and risk identification.
    • Provide QA expertise and guidance in:
      • GxP computerized systems classification.
      • System qualification and supplier assessment.
      • Change control and deviation management.
      • Regulatory and company compliance standards.
    • Evaluate and approve GxP applicability for computerized systems.
    • Manage the life cycle of GxP computerized systems, including:
      • Periodic reviews.
      • Change controls.
      • Deviation handling.
      • Risk mitigation strategies.
    • Ensure timely project support by reviewing and approving relevant documentation.

    Required Qualifications & Experience:

    Education & Skills:

    • University degree in Chemistry, Biology, Computer Science, or other relevant Life Sciences fields.
    • Fluency in Slovene and proficiency in English (written and spoken).
    • Proficiency in Microsoft Office tools.
    • Strong analytical and problem-solving skills, with a proactive approach to compliance challenges.
    • Excellent communication, decision-making, and organizational skills.
    • Ability to work independently, take initiative, and demonstrate reliability in a regulated environment.

    Experience Requirements:

    • For Expert-level role: Minimum 5 years of experience in Automation/Computerized System Validation (CSV) or Quality Assurance in a laboratory setting.
    • For Specialist-level role: Minimum 3 years of experience in Automation/CSV or Quality Assurance in a laboratory setting.

    What We Offer:

    • Competitive salary and annual bonus.
    • Flexible work schedule with hybrid/remote work options.
    • Permanent employment with a 6-month probation period.
    • Comprehensive pension scheme.
    • Employee Recognition Program.
    • Health and wellness benefits under the Energized for Life Program.
    • Unlimited learning and career development opportunities.

    Why Join Sandoz?

    Sandoz is a global leader in generics and biosimilars, delivering affordable, high-quality medicines to nearly 500 million patients annually.

    With cutting-edge production facilities, continuous investments in R&D, and strategic partnerships, Sandoz is shaping the future of the pharmaceutical industry.

    Our open, diverse, and collaborative culture provides an agile and flexible work environment where personal and professional growth is encouraged.

    Commitment to Diversity & Inclusion:

    Sandoz is committed to fostering an inclusive, equitable, and diverse workplace, ensuring our teams reflect the patients and communities we serve.

    How to Apply:

    Submit your application (CV in English or Slovene) by February 10, 2025 through the Sandoz Career Portal.

    If this role does not match your experience or career goals, you can still connect with us by joining the Sandoz Talent Network here.

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