QA Specialist TPN
Job description
About Tjoapack
Tjoapack is a global contract packaging organization (CPO) specializing in primary and secondary pharmaceutical packaging and supply chain management services. With a facility in EU and US each, we are dedicated to shaping the future of the pharmaceutical supply chain to be safer and more reliable for our customers and for patients. With more than 30 years of track record in contract packaging, we use our knowledge and experience to offer flexible solutions to our customers challenges and use the latest technologies to continuously improve our operations. Today, our operations serve more than 45 countries across all continents.
Why this role matters
As a QA Specialist, you will be the expert in Validation & Qualification (IQ, OQ, PQ). You are responsible for defining, executing, and continuously improving the validation and qualification strategy for processes, systems, equipment, and facilities in line with GMP and internal quality standards. You will provide guidance on regulatory requirements and best practices, lead validation activities, and represent Validation & Qualification during audits and inspections.
In addition, you will support other QA activities such as self-inspections, document management, deviations & complaints, supplier/customer management, and product quality reviews. Your primary focus, however, will be to ensure a robust validation and qualification process that guarantees the quality of our pharmaceutical products.
What you’ll do
SME Role in Validation & Qualification
- Serve as the subject matter expert for validation & qualification across packaging processes, equipment, facilities, and systems.
- Define, manage, and continuously enhance our lifecycle- and risk-based validation strategy.
- Lead, approve, and oversee validation activities, ensuring compliance with GMP and internal standards.
- Represent Validation & Qualification during audits and inspections, sharing your expertise with internal and external stakeholders.
Additional QA Activities
- Conduct self-inspections and improve processes for continuous compliance.
- Manage document control and support QMS activities.
- Handle deviations, complaints, CAPAs, and change controls efficiently and effectively.
- Support supplier and customer quality management (QTAs, audits).
- Execute Product Quality Reviews and lead continuous improvement initiatives
Who you are
- Bachelor’s degree in pharmaceutical, technical, or scientific field.
- Proven experience in validation & qualifications. Within a GMP-regulated environment is a plus.
- Skilled at investigating and resolving complex quality issues (root cause analysis).
- Knowledgeable about cGMP/cGDP and quality standards.
- Analytical, accurate, and detail-oriented, with a problem-solving mindset.
- Able to work independently while collaborating effectively across teams.
- Fluent in Dutch and English.
Why join Tjoapack?
- Make a tangible impact on global pharmaceutical supply chains and patient safety.
- Lead and shape Validation & Qualification practices in an international, growing organization.
- Work with a diverse, professional, and collaborative team.
- Enjoy a competitive salary, 30 days of leave, and an attractive pension scheme.
- Access opportunities for personal and professional growth, training, and continuous learning.
Ready to take the lead?
If you are a Validation & Qualification expert looking for a challenging, high-impact role where your work truly matters, we want to hear from you. Submit your CV and motivation via the “Apply Now” button and join us in shaping the future of pharmaceutical packaging.
- Job type
- Vast
- Posted
- 2025-12-23T00:00:00