Quality Assurance Specialist

2 months ago

Tianjin, Tianjin, China Novo Nordisk AS Full time
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk A/S. As a key member of our quality team, you will be responsible for ensuring the quality of our pharmaceutical products and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Quality Assurance: Ensure that all products are produced, tested, and released in accordance with relevant regulations, registration files, and quality specifications.
  • Regulatory Compliance: Participate in escalated deviations and ensure compliance with Novo Nordisk procedures.
  • Customer Complaints: Review customer complaints before case conclusion.
  • Quality Control: Review APR, including adverse event reports and ongoing stability study results.
  • Site Master File: Review the Site Master File.
  • Facility Management: Participate in decisions to start production in new facilities or changes to facilities/production lines.
  • Contract Manufacturing: Review service level agreements with contract manufacturers.
  • Critical Deviations: Approve critical deviations if necessary.
  • MA-3, MA-4 CR: Approve MA-3, MA-4 CR related to new products and equipment/facilities.
  • Product Specifications: Approve product and material specifications.
  • Quality Management System: Participate in relevant processes to maintain the QMS.
  • Internal Audits: Participate in internal audits and inspections.
  • Signal Process: Participate in signal process.
  • Quality Risk Management: Participate in QRM process, including QA oversight for core processes.
  • Validation Activities: Participate in validation activities, including QA oversight for complex validations.
  • Product Recall: Participate in product potential recall and actual recall.
  • International and National Complexity: Ensure compliance with marketing authorization, rules, regulations, and requirements regarding quality at site STJ and compliance to EU GMP annex 16 regarding contract manufacture and import to EU.
  • Counsel: Act as counsel in connection with quality issues across all sites.
  • Process Management: Establish and manage agile and compliant processes across AM/FPM and ensure alignment with external requirements and Novo Nordisk interpretation.
  • Expert Knowledge: In and on behalf of AM QA, efficiently share expert knowledge about and experience in key processes of high complexity and strategic importance.
  • cGMP Interpretation: Provide guidance and advice on cGMP interpretation in Product Supply to all levels of the organization, including QCVP and SVP levels.
  • Expertise: Recognized as the expert within own field of expertise by various stakeholders and so considered the obvious choice for solving complex problems.
  • Technical Responsibilities: Maintain License to Operate, ensure compliance with cGMP, ISO13485, and ensure audit and inspection readiness, including Training effectiveness, deviations, change requests, SOP updating, etc.
  • Quality Support: Provide quality support to production departments, ensuring that Q KPIs are fulfilled, balanced with timeliness and lead-time are in control.
  • Standardization and Optimization: Support standardization and optimization activities across boundaries.
  • Audit and Inspection: Key member of local Audit and Inspection in site TJ.
  • AM Q STJ Mgmt Meetings: Participate in AM Q STJ mgmt meetings as a member of the AM Q TJ mgmt team.
  • Geographic Responsibility: Position is geographically placed in Tianjin, QA responsibility in STJ.
  • Interaction with Health Authorities: Interaction with health authorities from countries worldwide as the position is key member of inspections.
  • Communication: Communicate directly with international and national stakeholders (MoC, Clayton, Chartres, DK).
Qualifications
  • Education: Bachelor's degree or Master's degree in Pharmacy, Biology, Chemistry, or related field.
  • Language: Excellent command of written and spoken English.
  • Experience: Minimum 10 years' experience from production or Quality area in GMP regulated pharmaceutical industry.
  • Audit and Inspection Experience: Full of experience in audit and inspection.
  • Regulatory Requirements: Have deep understanding and expertise in regulatory requirements and industry guidelines for validation.
  • Quality Systems and Standards: Broad experience with quality systems and standards applied by Novo Nordisk.
  • NN Way and Policies: Living NN Way and Novo Nordisk policies.
  • cLEAN Mindset: cLEAN mindset integrated with quality mindset.

  • Quality Assurance Specialist

    4 weeks ago

    Tianjin, Tianjin, China Novo Nordisk AS Full time

    Job Title: Quality Assurance SpecialistNovo Nordisk A/S is seeking a highly skilled Quality Assurance Specialist to join our team in Tianjin, China. As a key member of our quality team, you will be responsible for ensuring the quality of our pharmaceutical products and processes.Key Responsibilities:Ensure compliance with cGMP, ISO13485, and other relevant...

  • Quality Assurance Specialist

    2 weeks ago

    Tianjin, Tianjin, China Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk. As a Quality Assurance Specialist, you will be responsible for ensuring that our products meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesParticipate in the development and implementation of quality management...

  • Quality Assurance Specialist

    2 months ago

    Tianjin, Tianjin, China Novo Nordisk AS Full time

    About the PositionWe are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk A/S. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesProvide quality and compliance related input and make decisions on quality and...

  • Quality Assurance Specialist

    2 weeks ago

    Tianjin, Tianjin, China Novo Nordisk AS Full time

    Job Title: Quality Assurance SpecialistAre you a motivated professional looking to drive innovation in the pharmaceutical industry? Do you have a passion for ensuring the highest quality standards in product development and manufacturing? We are seeking a Quality Assurance Specialist to join our team at Novo Nordisk A/S.Key Responsibilities:Ensure compliance...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Tianjin, Tianjin, China Novo Nordisk Full time

    About the RoleWe are seeking a highly motivated and experienced Quality Assurance Specialist to join our team at Novo Nordisk. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes, and for implementing and maintaining our quality management system.Key ResponsibilitiesQuality Management...

  • Quality Assurance Specialist

    3 weeks ago

    Tianjin, Tianjin, China Novo Nordisk Full time

    Job Title: Quality Assurance SpecialistNovo Nordisk is seeking a highly skilled Quality Assurance Specialist to join our team in Tianjin, China. As a key member of our quality team, you will be responsible for ensuring the quality of our pharmaceutical products and processes.Key Responsibilities:Participate in the development and implementation of quality...

  • Quality Assurance Specialist

    1 day ago

    Tianjin, Tianjin, China Novo Nordisk Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk. As a Quality Assurance Specialist, you will be responsible for ensuring compliance with regulatory requirements, maintaining quality standards, and ensuring the integrity of our products.Key Responsibilities:Regulatory Compliance: Ensure compliance with...

  • Quality Assurance Specialist

    1 month ago

    Tianjin, Tianjin, China Novo Nordisk AS Full time

    Job Title: Quality Assurance SpecialistAre you passionate about ensuring the highest quality standards in the pharmaceutical industry? Do you have a strong background in regulatory compliance and quality management? We are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk A/S.Key Responsibilities:Ensure compliance with...

  • Quality Assurance Specialist

    3 weeks ago

    Tianjin, Tianjin, China Novo Nordisk AS Full time

    Transforming Treatment ParadigmsAre you driven by innovation and passionate about making a difference in the lives of patients? Novo Nordisk A/S is seeking a talented Quality Assurance Specialist to join our team and contribute to the development of life-changing treatments for chronic diseases.Key ResponsibilitiesProvide quality and compliance-related input...

  • Quality Assurance Specialist

    2 weeks ago

    Tianjin, Tianjin, China Novo Nordisk AS Full time

    Are you passionate about ensuring the highest quality standards in pharmaceuticals? Do you have a strong background in quality assurance and regulatory compliance? We are seeking a highly motivated and experienced Quality Assurance Specialist to join our team at Novo Nordisk A/S.Key Responsibilities:Provide quality and compliance related input and make...

  • Quality Assurance Specialist

    1 month ago

    Tianjin, Tianjin, China Novo Nordisk AS Full time

    Are you passionate about driving innovation in the pharmaceutical industry? Do you want to make a meaningful impact on the lives of patients? We're seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk A/S.Key Responsibilities:1. Quality and Compliance ExpertiseProvide quality and compliance-related input and make decisions...

  • Quality Assurance Specialist

    1 day ago

    Tianjin, Tianjin, China Novo Nordisk AS Full time

    About the RoleTransforming the Treatment ParadigmWe are seeking a highly experienced Quality Assurance Specialist to join our team at Novo Nordisk A/S. As a key member of our production team, you will play a critical role in ensuring the quality of our life-changing medicines.ResponsibilitiesEnsure Compliance with RegulationsImplement Quality Systems and...

  • Quality Assurance Specialist

    2 days ago

    Tianjin, Tianjin, China Huntsman Full time

    Role OverviewHuntsman's Polyurethanes division is seeking a Quality Assurance Specialist to support the establishment and maintenance of the quality system at the Tianjin factory.Key Responsibilities:Assist the quality manager in daily quality assurance and ensure timely resolution of product-related customer complaints, raw material problems, and...

  • Quality Assurance Specialist

    4 weeks ago

    Tianjin, Tianjin, China Huntsman Full time

    About the Role:Huntsman's Polyurethanes division is seeking a Quality Assurance Specialist to join their team in Tianjin, China.Key Responsibilities:Assist the quality manager in establishing, operating, and maintaining the quality system of the Tianjin factory, including ISO9001 and IATF16949 certification.Perform daily quality assurance activities and...

  • Senior Quality Assurance Specialist

    1 week ago

    Tianjin, Tianjin, China Novo Nordisk AS Full time

    Are you passionate about driving innovation in the pharmaceutical industry? We are seeking a Senior Quality Assurance Specialist to join our team at Novo Nordisk A/S. In this role, you will be responsible for ensuring the quality of our products and processes, and contributing to the development of our quality management system.Key ResponsibilitiesDevelop...

  • Quality Assurance Specialist

    2 weeks ago

    Tianjin, Tianjin, China Huntsman Full time

    Job SummaryHuntsman's Polyurethanes division is seeking a Quality Assurance Specialist to assist the quality manager in the establishment, operation, and maintenance of the quality system at the Tianjin factory. The successful candidate will be responsible for daily quality assurance, meeting production process requirements, and assisting in auditing...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Tianjin, Tianjin, China Novo Nordisk Full time

    About the RoleWe are seeking a highly motivated and experienced Quality Assurance Specialist to join our team at Novo Nordisk. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our pharmaceutical products and processes.Key ResponsibilitiesQuality Management ReviewSite Self-Inspection and Quality...

  • Software Quality Assurance Professional

    1 day ago

    Tianjin, Tianjin, China Volvo Group Full time

    Software Quality Assurance ProfessionalWe are seeking a highly motivated and detail-oriented Software Quality Assurance Professional to join our team at Volvo Group. As a QA Professional, you will play a critical role in ensuring the quality of our software applications.Key Responsibilities:• Collaborate with cross-functional teams to identify and...

  • Quality Assurance Specialist

    1 day ago

    Tianjin, Tianjin, China Novo Nordisk AS Full time

    Contribute to Innovation in Patient CareAt Novo Nordisk A/S, we are driven to change the treatment paradigm for chronic diseases that rely on injection-based therapies. As a key member of our quality assurance team, you will play a vital role in ensuring the quality and compliance of our products.Responsibilities1. Provide quality and compliance-related...

  • Senior Quality Assurance Engineer

    4 weeks ago

    Tianjin, Tianjin, China Novo Nordisk AS Full time

    Transforming Treatment Paradigms for Chronic DiseasesAre you driven by innovation and passionate about making a difference in the lives of patients? Do you have a strong background in quality assurance and a desire to lead the way in transforming treatment paradigms for chronic diseases? We're seeking a highly motivated and experienced Senior QA Engineer to...