QA Specialist

Introduction:

We dream of a world where no medical need goes unmet. Suffering or dying because of a lack of medicines is inhumane. That’s why we do whatever it takes to create better access to medicine for people around the globe. Our job is done when every person on this planet has access to the right medication & medical supplies at the right place and time. And we know how.

Since 2005, i+solutions has set the industry standard for health procurement. We drive an innovative agenda to improve global health supply chains. We combine procurement, training, project management, quality assurance and technical expertise to make a difference from the first to the last mile, closing the gap between patients and medicine.

Big dreams ask for big solutions. That’s why we work with global donors, countries and partners to make a difference daily. These partnerships enable us to scale our solutions, drive industry innovation, and conquer new challenges. Together, we combine big hearts with big data to improve supply chains that secure accessibility and care. We’re here to close the gap. And together, we can!

Role description:

As QA Specialist, you will be reporting to the Head of Quality Assurance and Risk Management. In the role of Quality Assurance Specialist you will operate our Quality Management System in order for i+solutions to achieve our Quality Goals. In doing so you need to collaborate with other departments in order to align QA and company goals. As we are a relatively small and purpose driven organization your role is broad and touches several organizational areas from a quality assurance perspective. In this role you help the access to medicine to all that are in need of them through ensuring a continuous supply of good quality medicine. i+solutions is a GDP and ISO9001: 2015 certified organization. Due to the expansion of our activities, we are currently looking for a new colleague.

Responsibilities:

  • Management of the pharmaceutical and GDP documentation system
  • Review and approval controlled documents
  • Issuance and retrieval of controlled documentation
  • Archiving of controlled documentation in a compliant manner
  • Direct point of contact with internal stakeholders
  • Support the organization in the creation of Standard Operating Procedures.
  • Providing support to the electronic DMS and Quality Management system
  • Management of QC testing
  • Subject Matter Expert of Document Management System
  • Provide support during audits
  • Support and participate in continuous improvement initiatives DMS
  • Provide customer satisfaction survey support
  • Support the team with daily operations activities

Qualifications

  • HBO working and thinking level
  • 3+ years background in QA role within Life Science environment
  • 3+ years of experience with GDP, MQAS and preferable GMP standards/certification
  • Thorough knowledge of ISO standards 9001, and preferable knowledge 14644 and 17137, ISO13485 is an advantage
  • Relevant work experience in management and maintenance of a (pharmaceutical) documentation system
  • Excellent oral and written communication skills, proficient in MS Office. (Teams, Word,Excel, Outlook)
  • Fluency in English is required, competence in Dutch or any other language is highly valued.
  • Personal and professional skills:
  • Enthusiastic team player and able to demonstrate integrity in all dealings with colleagues, customers, regulators and other professionals.
  • Pro-active approach and problem-solving skills.
  • Open minded and able to build strong, open dialogue-based relationships with relevant stakeholders.
  • Action oriented with a strong focus on completing tasks accurately and efficiently Quality Awareness

What we offer:

  • Working in a great team and a pleasant atmosphere
  • A drive for purpose and a multi-cultural environment
  • Teaming with professionals that put passion into our Mission
  • Good compensation package and excellent opportunities for personal development

Values and background check

i+solutions has a zero-tolerance policy against sexual exploitation and abuse.i+solutions may conduct background and reference checks on applicants who accept job employment offers. Please apply with your CV and cover letter telling us why you think you would be a great fit for this position careers@iplussolutions.org.

                                         Apply now​

 

Please apply with your CV and cover letter telling us why you think you would be a great fit for this position:​

careers@iplussolutions.org

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