Biologics QA & Compliance Specialist

SUN PHARMA; Hoofddorp; Sur place; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

25 holidays

1 extra day off on your birthday

Résumé du poste

A multinational pharmaceutical company is looking for a QA Specialist Biologics in Hoofddorp, Netherlands. The role involves ensuring compliance for Biologic products, overseeing quality assurance activities, and conducting inspections. Candidates should possess a Bachelor's degree in Chemistry, Pharmacy, or related field and 5 years of experience in (bio) pharmaceuticals. Strong knowledge of EU GMP regulations and excellent communication skills are essential. The company offers an international work environment, 25 holidays, plus an extra day off on your birthday.

Qualifications

• 5 years of relevant experience in (bio) pharmaceutical Drug Substance and/or Drug Product manufacturing.
• Advanced knowledge and experience in API/DP biopharmaceutical operations, QA/QC processes and contract manufacturing.
• Good understanding of complex change control processes and regulatory submission processes.

Responsabilités

• Manage QA batch release planning of Biologic products.
• Review batch documentation for compliance with GMP.
• Support the maintenance of the Quality Management System.

Connaissances

Strong knowledge of EU GMP

Excellent communication skills

Strong interpersonal skills

Problem-solving abilities

Experience with electronic Document Management

Well versed in Microsoft Excel

Formation

HBO or Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or similar education

Outils

Microsoft Office

Trackwise

Description du poste

A multinational pharmaceutical company is looking for a QA Specialist Biologics in Hoofddorp, Netherlands. The role involves ensuring compliance for Biologic products, overseeing quality assurance activities, and conducting inspections. Candidates should possess a Bachelor's degree in Chemistry, Pharmacy, or related field and 5 years of experience in (bio) pharmaceuticals. Strong knowledge of EU GMP regulations and excellent communication skills are essential. The company offers an international work environment, 25 holidays, plus an extra day off on your birthday.