Quality Assurance Consultant

23 hours ago

Belgrade, Central Serbia 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 Coordinator

    1 week ago

    Belgrade, Central Serbia PrimeVigilance Full time €35,000 - €45,000 per year

    Company DescriptionWe are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...

  • Quality Assurance Manager

    23 hours ago

    Belgrade, Central Serbia Proctorio Full time €25,000 - €50,000 per year

    Quality Assurance ManagerPosition Overview:As the Quality Assurance Manager, you will be responsible for ensuring that all projects maintain timely test plans and that tasks are promptly updated after testing. You will oversee the resolution of failed tasks and confirm that all roadmap items are supported by complete test cases and plans. In addition, you...

  • Quality Assurance Intern

    1 week ago

    Belgrade, Central Serbia BlueCat Full time €30,000 - €50,000 per year

    Have you heard of BlueCat? We're one of those hidden gems that's been disrupting the market as a key player in the rapidly growing space of Intelligent Network Operations. Organizations require a new model of network operations that links foundational core services with a deep, predictive understanding of network health and performance to improve change...

  • Quality Assurance Test Engineer

    2 weeks ago

    Belgrade, Central Serbia Daon Full time €104,000 - €130,878 per year

    Location: Belgrade and Novi SadHybrid: this role requires working from the office two days a week.Want to learn about biometric verification and work with the latest generation smart phone technologies? Interested in learning new platforms and new technology? This is the job for you Daon is an innovative provider of award-winning biometric identity assurance...

  • Quality Assurance Intern

    1 week ago

    Belgrade, Central Serbia BlueCat Full time €20,000 - €40,000 per year

    Have you heard of BlueCat? We're one of those hidden gems that's been disrupting the market as a key player in the rapidly growing space of Intelligent Network Operations. Organizations require a new model of network operations that links foundational core services with a deep, predictive understanding of network health and performance to improve change...

  • Senior Software Quality Assurance Engineer

    23 hours ago

    Belgrade, Central Serbia microTECH Global LTD Full time €60,000 - €80,000 per year

    We are seeking an experienced QA engineer to develop and implement testing programs for our software-defined hardware solution, and integrate them into the system-level test environment.RequirementsBSc in either computer science or a closely related fieldAt least 10 years of relevant industry experienceExperience with manual testing, automation systems,...

  • Quality Assurance Engineer II

    1 week ago

    Belgrade, Central Serbia Everseen Full time €40,000 - €80,000 per year

    Everseen: A leader in vision AI solutions for the world's leading retailers.The RoleAs a Quality Assurance Engineer at Everseen, you will be an integral part of our dynamic team, responsible for testing, automating test design and implementations. You will have the opportunity to collaborate with talented professionals and contribute to the development of...

  • Functional Consultant MES

    3 days ago

    Belgrade, Central Serbia Enabl3 Full time €30,000 - €60,000 per year

    ENABL3 DOO is a fast-growing consultancy firm that specializes in digitizing shop-floor processes in the pharmaceutical industry. We are currently seeking ambitious individuals who are either experienced MES (Manufacturing Execution Systems) consultants or interested in becoming one. As we expand globally, we are looking for driven candidates to help...

  • Quality Assurance Engineer II

    1 week ago

    Belgrade, Central Serbia Everseen Full time €30,000 - €60,000 per year

    Everseen: A leader in vision AI solutions for the world's leading retailers.The Role:As a Quality Assurance Engineer at Everseen, you will be an integral part of our dynamic team, responsible for testing, automating test design and implementations. You will have the opportunity to collaborate with talented professionals and contribute to the development of...

  • Senior Consultant

    23 hours ago

    Belgrade, Central Serbia Law Debenture Full time 30,000 - 60,000 per year

    About Law Debenture Law Debenture is an Investment Trust supported by a wholly owned professional services business. LawDeb is an unusual and exciting proposition; on a day–to-day basis we are nimble, ambitious and small enough to know everyone by name, whilst also benefiting from the profile and credibility of a listed business. This is thanks to our...