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    Quality Assurance Operations Technician

    Novartis
    3+ years
    Not Disclosed
    Barcelona
    10 Jan. 31, 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 Operations Technician - TEMPORAL

    Location: Barcelona Palafolls, Sandoz
    Job Type: Full-time (Temporary)
    Application Deadline: Not specified

    Job Summary:

    As a Quality Assurance Operations Technician, you will be responsible for ensuring the adherence to Good Manufacturing Practices (GMP) within the production processes at Sandoz Industrial Products in Palafolls. You will review batch records, oversee the quality assurance of chemical processes, handle deviations, and manage quality control for manufactured products. Your role also includes the analysis of trends, investigation follow-up, and ensuring compliance with Novartis quality standards. This position will contribute to maintaining the high standards of quality in the manufacturing environment and support the “Culture of Quality” within the organization.

    Key Responsibilities:

    Quality Assurance & Process Monitoring:

    • Batch record review: Evaluate batch records of products manufactured in Sandoz Industrial Products SA according to established quality system procedures and relevant records.
    • API release & quarantine management: Approve and authorize the release of Active Pharmaceutical Ingredients (APIs) and manage shipments in quarantine.
    • Oversight of chemical processes: Ensure compliance with GMP and Novartis quality requirements across manufacturing processes.
    • Investigation management: Follow up on deviations (OOS/OOE/OOL) and manage corrective and preventive actions (CAPA).
    • KPI tracking and trend analysis: Monitor key performance indicators (KPIs) and analyze trends to improve process performance.

    Documentation & Regulatory Compliance:

    • Review of HSF for sterile APIs: Ensure correct review and decision-making regarding the use of API batches, ensuring compliance with customer specifications and quality procedures.
    • Analytical results review: Verify the analytical results of batches, including chemical, physical, and microbiological tests, and ensure the raw materials and intermediates meet release criteria.
    • Documentation management: Approve and review change controls, batch records, specifications, and associated documentation.
    • Interpret and apply quality standards: Apply guidelines, manuals, SOPs, and other quality standards to ensure GMP compliance in all areas of production.

    Continuous Improvement & Training:

    • Support "Culture of Quality": Encourage the implementation of quality standards across departments and foster a culture of quality in all areas of the company.
    • Deviation management: Participate in investigations into production deviations and assess the impact of non-conformance on production processes.
    • Training & development: Stay updated on the latest quality standards and ensure your training curriculum is current. Provide necessary support and training for new team members.
    • Actionable recommendations: Proactively recommend and manage corrective actions based on deviation management principles.

    Health, Safety, and Compliance:

    • Safety & environmental regulations: Comply with safety, environmental, and quality regulations within the plant and contribute to emergency plans.
    • Code of Conduct & Integrity: Ensure compliance with the company’s Code of Conduct and integrity standards.
    • Customer complaints: Manage and monitor customer complaints related to quality issues.

    Qualifications & Experience:

    Education:

    • University degree in Health Sciences, preferably in Pharmacy, Biology, or a related field.

    Experience:

    • 3+ years of experience in Quality Assurance within the pharmaceutical industry, specifically with GMP monitoring.
    • Familiarity with sterile environments will be a plus.

    Skills & Expertise:

    • Fluent in Spanish, with a minimum B2 level of English.
    • Strong understanding of GMP practices and quality assurance procedures.
    • Ability to evaluate and ensure compliance with GMP standards, including batch record review and deviation management.
    • Proficient in trend analysis and KPI tracking to monitor quality improvements.

    Why Sandoz?

    Sandoz, a leader in the generic and biosimilar medicine market, is committed to improving global health by providing affordable, high-quality medicines. Joining Sandoz means contributing to a collaborative, inclusive environment where innovation thrives, personal growth is encouraged, and impactful careers are built.

    Commitment to Diversity & Inclusion:

    Sandoz is dedicated to creating a diverse and inclusive work environment. The company values and respects differences and is focused on building teams that reflect the communities and patients we serve.

    Compensation & Benefits:

    • Competitive salary package
    • Opportunities for personal and professional growth in a global company
    • Flexible and hybrid working options
    • Collaborative and diverse work environment

    Note:

    For more career opportunities, join the Sandoz Talent Pool.

     

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