Quality & Assurance Manager

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.

Role description:

As QA Manager at senior level, you will be reporting to the Head of Quality Assurance and Risk Management. Next to being responsible for Internal/External Audits, your position will also entail responsibility for Audit management, planning and contact with auditors and verify Regulation and Standard updates.

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:

  • Responsible for Internal/External Audits, policy and procedures and ensures that all processes are audited according to the defined periods
  • Providing Audit reports in time manner
  • Audit management (ISO, MQAS and GDP), planning and contact with auditors
  • Inspect Recalls and Warning letters on impact on organization
  • Verify Regulation and Standard updates
  • Management of Quality Agreements with the clients
  • Management of CAPA system
  • Subject Matter Expert for Audits
  • Continuous Improvements of Audits process
  • Provide customer satisfaction survey support
  • Support the team with daily operations activities

Qualifications

  • Academic working and thinking level
  • 10+ years background in a QA role within Life Science environment
  • 10+ years of experience with GDP, MQAS and preferable GMP standards/certification
  • 10+ years of experience of Internal/External audits
  • Thorough knowledge of ISO standards 9001, and preferably knowledge of 14644 and 17137, ISO13485 is an advantage
  • Knowledge / experience with met MS-Office (Word, Excel, Outlook)
  • Dutch and English language proficiency at a professional level, other languages are appreciated

Competencies

  • 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.
  • 30 vacation days (on full time basis)
  •  

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.

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

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