Quality Assurance Specialist (Senior Level)

SIRE LIFE SCIENCES; Haarlem; On-site; EUR 65,000 - 90,000; Full time

Job summary

SIRE LIFE SCIENCES is seeking an experienced Quality Assurance Specialist to oversee the release of pharmaceutical products in Haarlem. You will inspect, review, and authorize documentation, manage quality investigations, and support regulatory inspections.

Responsibilities include approving master documents, leading deviation investigations, and coordinating quality improvements to minimize production risks.

Qualifications

• Proficient in analytical methods.
• Strong understanding of EU and US pharmaceutical regulations.
• Experience with aseptic processes is preferred.

Responsibilities

• Review and approve master documents and specifications to support product release.
• Initiate and evaluate quality investigations, including deviations, to determine release or rejection, and implement improvements.
• Ensure timely completion of deviation and investigation reports.
• Lead quality improvement initiatives to control production risks.
• Authorize ongoing stability studies and Product Quality Reviews.
• Prepare for and oversee inspections by government agencies and customers.
• Participate in self-inspections across production, laboratory, storage, and distribution areas.
• Support and coordinate handling of complaints, root cause analysis, and corrective actions.
• Manage product recalls and stock blockage proposals.
• Investigate and document deviations and complaints thoroughly.
• Develop and maintain relationships with external partners related to quality oversight.
• Participate in technology transfer activities and contribute to process improvements.
• Provide functional leadership to QA team members, including organizing work and staffing decisions.

Skills

Analytical methods

Aseptic manufacturing

Regulatory knowledge

Process improvement

Documentation and reviews

Education

Pharmacy/chemistry/biology degree

Job description

Company:

Our client is a leading organization in the pharmaceutical industry, dedicated to ensuring the highest standards of product quality and compliance. They operate within a heavily regulated environment, committed to delivering safe and effective medicines to the market.

Job Description:

We are seeking an experienced Quality Assurance Specialist to oversee the release of pharmaceutical products, ensuring all are compliant with applicable laws, regulations, and internal standards. This key role involves inspecting, reviewing, and authorizing product documentation, managing quality investigations, and supporting regulatory inspections.

Responsibilities:

• Review and approve master documents and specifications to support product release.
• Initiate and evaluate quality investigations, including deviations, to determine release or rejection, and implement improvement proposals.
• Ensure timely completion of deviation and investigation reports.
• Lead quality improvement initiatives to control production risks.
• Authorize ongoing stability studies and Product Quality Reviews.
• Prepare for and oversee inspections by government agencies and customers.
• Participate in self-inspections across production, laboratory, storage, and distribution areas.
• Support and coordinate handling of complaints, root cause analysis, and implementation of corrective actions.
• Manage product recalls and stock blockage proposals.
• Investigate and document deviations and complaints thoroughly.
• Develop and maintain relationships with external partners related to quality oversight.
• Participate in technology transfer activities and contribute to process improvements.
• Provide functional leadership to QA team members, including organizing work, implementing structured procedures, and contributing to staffing and training decisions.

Requirements:

• Degree in pharmacy, chemistry, biology, or a related field (per EU Directive 2001/83/EC).
• Extensive experience with aseptic manufacturing processes (preferably over 5 years).
• Knowledge of lyophilization and visual inspection processes is a plus.
• Familiarity with automated pharmaceutical processes.
• Strong understanding of EU and US pharmaceutical laws and regulations.
• Proficient in analytical methods.