Sr. QA Consultant

at  TailorMinds

CLIENT

Our client is a respected partner for life sciences companies.
Client
Our client is a respected partner for life sciences companies. Providing knowledge and expertise in phases ranging from drug development to commercial manufacturing. One of their expertises is the engineering, commissioning and qualification in pharmaceutical projects. Currently they are looking for a Validation Consultant to strenghten their team of Consultants.

REQUIREMENTS

• University or Higher Professional Education (HBO) degree in Biotechnology, Chemical Technology, Biochemistry, Pharmacy or similar.
• Relevant work experience in the (bio-)pharmaceutical industry, within different companies.
• Experience with IGJ or FDA inspections, preferably in a leading role.
• Broad project management experience.
• Extensive knowledge of pharmaceutical production and familiarity with cGMP requirements and other relevant regulations and guidelines, for example for quality management systems.
• Experience in designing and implementation of quality improvement plans, policies, procedures and management reports.
• Effective communication skills.
• High proficiency in Dutch and English.
• Pro-active, pragmatic, flexible and customer-oriented.

• Dependent upon the assignment, you lead a significant quality improvement project or you implement a quality management system.
• Leader inspection readiness programs.
• Act as an ad-interim quality manager or director.
• Support the client in the development, implementation, training and evaluation of their quality systems to ensure acceptance in the client’s organization and operations.
• Lead and perform audits, gap analyses and risk assessments.