Quality Control Analyst

7 maanden geleden

Leiden, Nederland ClinChoice Voltijd

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds.

ClinChoice, is searching for a Quality Control Analyst to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work in a hybrid model in Leiden, 1.0 FTE for a 6-month contract.

The Quality Control Analyst acts as a quality expert and applies Company's Quality Systems to create, review and approve GMP documentation. The contractor works in close collaboration with other departments (Operations, QC, Planning, R&D etc.).

**Main Job Tasks and Responsibilities**:

- Paper and electronic batch record review.
- Raw material release.
- Document revisions review and approval.
- Review and approve analytical method transfer protocols and reports.
- Review and approve change controls, validation protocols and reports, validation assessments, and appliable lifecycle documentation depending on experience.
- Track and monitor progress of changes to anticipate, flag and prevent any delays in change implementation.
- Depending on experience supporting master material changes.

**Education and Experience**:

- BSc/HBO (or equivalent) in bioscience, chemistry, pharmacy or equivalent.
- One or more years of QA experience in pharmaceutical or related industry.
- Experience in Change control and all documenting related activities.

**Specific Role Requirements and Skills**:

- Up to date knowledge of current GMP regulations
- Experience with documentation systems like Trackwise, True Vault is preferable.
- Good communicative and advisory skills in English, both (verbal and written), understanding of Dutch.
- Able to work independently as well as in a team.

**The Application Process**:
**Who will you be working for?**

**About ClinChoice**:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

**Our Company Ethos**:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

**Key words**: Quality Control Analyst, Quality Assurance, GMP, CAPA, Validation batches, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

LI-CM1 #LI-HYBRID #CONTRACT

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