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Sr. QA Associate

QA Officer
Leiden

For an international pharmaceutical client in the area of Leiden I am looking for a QA Officer. You will be working within the quality department where you will be responsible for overseeing and supporting the quality systems and projects by external collaborations.

As the QA Officer you will assure compliance with regulatory requirements and internal procedures via appropriate oversight and planning, conducting, and reporting quality inspections, report audits, internal and external facility evaluations, system audits, and data reviews that support company late stage development projects. Furthermore, you will support release activities.

What are your responsibilities?
* Supplier management including auditing, monitoring and maintenance of Quality agreements suppliers including external manufacturing, laboratories, GMP services and GMP raw material suppliers.
* QA oversight of validation, qualification activities connected to drug substance and drug product manufacturing.
* Assesses compliance with regulations for late stage development matters.
* Participates in regulatory agency inspections, (global) project team meetings, and training activities.
* Communicates effectively with professional staff and leadership across departments.
* Effective stakeholder manager, able to influence. The 'go-to' person on difficult content issues.
* Challenges the status-quo. Involved in conception of new ideas with respect to improvement of business processes or procedures.
* Leads the execution of systems aimed at evaluating and maintaining quality and compliance.
* Is able to independently prepare batch (DS and DP) dossiers to facilitate technical release.

What skills do you bring?
* MSc in a relevant discipline, like Pharmacy or Bio-Pharmaceutical Sciences
* Minimal 8 years of experience, of which 5 years relevant to this position (industrial setting/manufacturing and/or Quality Assurance area).
* Technically skilled (DS and DP manufacturing, Quality Systems, Process Validation, etc).
* Independent and organized accurate worker, with eye for detail and good writing skills.
* Is pro-active in the identification of issues, has problem-solving capabilities.

Details:
* Competitive salary range
* Start date: ASAP
* Location: Leiden
* Contract: 6 months


Are you available per direct and would you like to apply for this position? Please do not hesitate to contact Celine Stevens by sending an email to c.stevens[at]realstaffing.com or call 020 522 1588.