Quality Assurance Specialist
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.
The Role | Main Responsibilities
As QA Specialist, you will be reporting to the Head of Quality Assurance. Next to being responsible for maintaining quality records and processes, your position will also entail responsibility for client project implementations, vendor and product qualifications, GDP compliance, improvement projects and verify Regulation and Standard updates.
i+solutions is a GDP and ISO9001: 2015 organization that delivers products throughout the world based on unmet medical needs. Due to the expansion of our activities, we are currently looking for a new colleague. Have you been working in QA for quite some time in a cGxP environment and looking for a new challenge? This might just be the job for you!
In this role the QA specialist helps the access to medicine to all that are in need of them through ensuring a continuous supply of good quality medicine.
Specific Responsibilities
- Responsible for maintaining quality records and documentation for clients
- Qualifying wholesalers, suppliers and products
- Inspection preparation coordination and resolution
- 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 QMS-system or related processes.
- Complaint management
- Subject Matter Expert for Audits
- Continuous Improvements of QMS processes
- Provide customer satisfaction survey support
- Support the team with daily operations activities
Qualifications
- Academic working and thinking level, preferably in Pharmacy or Life Sciences
- 3-5 years background in a QA role within Life Science environment
- 2+ years of experience with GDP, preferable MQAS and GMP standards/certification
- Experience in inspectorate preparation and management activities
- 3+ years of experience with vendor and product qualifications, not withstanding audits
- Thorough knowledge of ISO standards 9001, and preferably knowledge of 14644 and 17137, ISO13485 and ISO 31000 experience is an advantage
- Eligible to work as an RP in EU
- Experience with maintaining quality records and DMS/QMS-related processes. GAMP5 implementation experience is preferable
- Knowledge / experience with met MS-Office (Word, Excel, Outlook)
- Dutch and English language proficiency at a professional level, other languages are appreciated
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
- Resolute
- Result and service oriented
- Precise and accurate
Behavioural components
- Diligent and detail oriented
- Effective communication skills with an energetic approach
- Strong planning and prioritizing skills
- Open minded, solution orientated and positive mindset
- Ability to enjoy working and managing a multicultural team
- Flexible & Resilient
What we offer:
- Working in a great team and a pleasant atmosphere
- A drive for purpose and a multi-cultural environment
- Teaming with professionals who put passion into our mission
- Excellent opportunities for personal development
- Travel expenses compensation
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.
Apply now!
Please apply with your CV and cover letter telling us why you think you would be a great fit for this position:
