Quality Assurance Consultant

17 hours ago

Bucharest, Bucureşti, Romania PharmEng Technology Full time €30,000 - €60,000 per year

Job Summary: The Quality Assurance Consultant is responsible for the implementation, maintenance, and oversight of the Quality Management System (QMS) in local affiliates. This role ensures compliance with regulatory requirements, quality standards, and company policies. The Quality Assurance Consultant will manage quality risk, complaints, change controls, deviations, CAPA, authority inspections, self-inspections, GxP surveillance, product quality reviews, training, local product release, and oversight of GDP requirements for local warehousing and distribution.

Key Responsibilities:

  • QMS implementation, maintenance, and oversight in local affiliates.
  • Maintenance of the local Quality Manual and Site Master File.
  • Quality risk management in local affiliate, including risk identification, analysis, communication, control, and escalation as required.
  • Complaint management, acting as the Local Complaint Coordinator for reporting, local assessment, and local investigation.
  • Change control management, QA assessment, site change control, QA review for change implementation and closure.
  • Deviation management for internal, external, and transport deviations.
  • CAPA management from deviations, internal audits, external audits, and self-inspections.
  • Management of authority inspections and self-inspections.
  • Local GxP surveillance and assessment.
  • Product quality review (PQR).
  • Training management, including maintenance of training matrix, training of local staff, annual GxP refresher training, and handling of training assignments in the LMS.
  • Local product release (local QP), shipment review of transport performance, goods receipt check, and deviation handling.
  • Oversight of GDP requirements for local warehousing and distribution.
  • Shipping lane qualification and local transport performance of secondary distribution.
  • Secondary distribution transport performance review.
  • Return management, including QA evaluation against return criteria and collaboration with distributors.
  • Product recall management, including local recall execution, communication with customers, communication with HA, recall reconciliation, and local product destruction.
  • GxP suppliers management, including supplier identification, qualification, approval, annual compliance status evaluation, quality audit planning, conduct quality audits, and CAPA approval and closure.
  • Local repackaging and relabeling, including change management, protocol, execution, QA review, and release.

Qualifications:

  • Bachelor's degree in Quality Management, Life Sciences, or a related field.
  • Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or healthcare industry.
  • Strong knowledge of GxP regulations and quality standards.
  • Excellent analytical, problem-solving, and communication skills.
  • Ability to work independently and collaboratively in a team environment.
  • Proficiency in using Quality Management Systems and Learning Management Systems (LMS).

Key Competencies:

  • Attention to detail and accuracy.
  • Strong organizational and time management skills.
  • Effective leadership and team management abilities.
  • Proactive and results-oriented mindset.

  • Quality Assurance Consultant

    2 weeks ago

    Bucharest, Bucureşti, Romania Chain IQ Full time 40,000 - 60,000 per year

    Title: Quality Assurance ConsultantLocation:Bucharest, RODate: Oct 6, 2025At Chain IQ, your ideas move fast.Chain IQ is a global AI-driven Procurement Service Partner, headquartered in Baar, Switzerland, with operations across main centers and 16 offices worldwide. We provide tailored, end-to-end procurement solutions that enable transformation, drive...

  • Quality Assurance Consultant

    2 weeks ago

    Bucharest, Bucureşti, Romania chainiqgro Full time 40,000 - 60,000 per year

    At Chain IQ, your ideas move fast.Chain IQ is a global AI-driven Procurement Service Partner, headquartered in Baar, Switzerland, with operations across main centers and 16 offices worldwide. We provide tailored, end-to-end procurement solutions that enable transformation, drive scalability, and deliver substantial reductions in our clients' indirect spend....

  • Quality Assurance Auditor

    5 days ago

    Bucharest, Bucureşti, Romania AZGROUPPROD Full time 30,000 - 60,000 per year

    Allianz Services is proud to serve and be part of Allianz Group, one of the world's leading insurers and asset managers. Our global footprint, with more than 7,300 employees located across ten countries and four continents, enables us to unlock value for our partners across the insurance value chain and deliver superior client experience within Allianz...

  • Functional Quality Assurance

    1 week ago

    Bucharest, Bucureşti, Romania Inetum Full time 15,000 - 30,000 per year

    Company DescriptionOrganization Our Mission Statement Digital and human resources at the center of the sustainable development of our society. In a world of continuous transformation, accelerated by technological developments and societal challenges, it is necessary to adapt in an ongoing, agile way to meet the challenges of the future. About Inetum ...

  • Functional Quality Assurance

    1 week ago

    Bucharest, Bucureşti, Romania Inetum Full time €40,000 - €60,000 per year

    Company Description OrganizationOur Mission StatementDigital and human resources at the center of the sustainable development of our society.In a world of continuous transformation, accelerated by technological developments and societal challenges, it is necessary to adapt in an ongoing, agile way to meet the challenges of the future.About InetumInetum is a...

  • Quality Assurance Engineer

    1 week ago

    Bucharest, Bucureşti, Romania OPEN Full time 30,000 - 40,000 per year

    We are looking for a dedicated and passionateQuality Assurance Engineerto join our growing development team. If you have a solid understanding of testing processes this role is perfect for you.Responsibilities:Generate test cases in Postman (POST/PUT/UPDATE)Networking: API EndpointsAnalyze network/console/application in the browserDesign and execute test...

  • Quality Assurance Engineer

    1 week ago

    Bucharest, Bucureşti, Romania Ampstek Full time 40,000 - 60,000 per year

    Quality Assurance Engineers(Product : Fluent Commerce)-Collaborate closely with the OMS team to understand functional requirements and testing needs.-Design, develop, and execute regression test cases to ensure system stability across releases.-Perform feature validation to confirm new functionalities meet business and technical expectations.-Develop and...

  • Functional Quality Assurance

    2 weeks ago

    Bucharest, Bucureşti, Romania Societe Generale Global Solution Centre Romania Full time €15,000 - €30,000 per year

    Reference 25000JFRResponsibilitiesYour future team :Societe Generale Group's Insurance business is at the heart of the group's development, in synergy with all the Retail Banking, Private Banking and specialized financial services businesses, in France and abroad. Its main challenge is to design and deliver fast, easy-to-use IT solutions that are innovative,...

  • Functional Quality Assurance

    1 week ago

    Bucharest, Bucureşti, Romania Societe Generale Full time €20,000 - €40,000 per year

    ResponsibilitiesYour future team :Societe Generale Group's Insurance business is at the heart of the group's development, in synergy with all the Retail Banking, Private Banking and specialized financial services businesses, in France and abroad. Its main challenge is to design and deliver fast, easy-to-use IT solutions that are innovative, scalable and...

  • Functional Quality Assurance

    5 days ago

    Bucharest, Bucureşti, Romania Société Générale Full time 15,000 - 30,000 per year

    ResponsibilitiesYour future team :andnbsp; Societe Generale Groupandrsquo;s Insurance business is at the heart of the groupand#39;s development, in synergy with all the Retail Banking, Private Banking and specialized financial services businesses, in France and abroad. Its main challenge is to design and deliver fast, easy-to-use IT solutions that are...