QA Manager

• Ensure that all QA department activity is performed in accordance to procedures and client instructions and that everything appropriately documented.
• Support the business in maintaining compliance to GDP, GMP, ISO 9001 and client requirements

Description

• Providing QA oversight for all operations
• Managing daily Quality oversight within companies Distribution and Manufacturing facility.
• Supporting or hosting regulatory inspections by Dutch Health Authorities
• Maintaining knowledge of applicable regulations
• Maintaining awareness of client requirements as specified in respective Quality/Technical Agreements
• Ensuring that quality incidents, client / customer complaints and deviations are appropriately recorded, investigated, corrective actions identified and communicated.
• Ensuring that all direct reports are trained in GDP and GMP and other relevant procedures
• Ensuring changes are appropriately documented, reviewed, approved, and controlled
• Performing internal and supplier audits
• Maintain the WDA and MIA conjunction with the licence holder.
• Maintaining and managing the relationship with contract QP's where applicable

• Maintaining and reviewing a site Validation Master Plan (sVMP)
• Writing protocols for qualification and validation activities;
• Reporting on completed qualification and validation activities.

• Monitoring direct reports in the continuous development of their skills and ensuring all direct reports are sufficiently trained.
• Conducting regular performance reviews and a performance appraisal with each direct report.

Member of Management Team

To carry out any reasonable request from senior management as required and according to business needs

Job Offer

• Competitive Salary
• Company Car
• Bonus possibility