Quality Assurance Specialist

SIRE LIFE SCIENCES; Breda; On-site; EUR 55,000 - 75,000; Full time

Job summary

SIRE LIFE SCIENCES in the Netherlands seeks a Quality Assurance Specialist to provide quality oversight and GMP support in a manufacturing environment. This role partners with Production, Engineering and Quality to ensure compliance, review batch records, and drive continuous improvement.

You will participate in deviations, investigations, SOP authoring, and GMP training, with a rotating shift schedule and potential transition to five shifts.

Qualifications

• Minimum 3 years of Quality Assurance or pharmaceutical manufacturing experience.
• Experience with batch record review and investigations.
• Strong understanding of GMP regulations and quality systems.
• Fluent English communication skills and ability to train colleagues.

Responsibilities

• Provide QA guidance and support to production operations.
• Review and approve batch production records before manufacturing activities begin.
• Perform batch record reviews for assembled, packaged, and labeled products.
• Conduct finished product quality checks during production runs.
• Act as first point of contact for quality related production questions.
• Perform GMP compliance checks within the manufacturing area.
• Review, approve, and manage deviation records.
• Initiate and own quality deviations when required.
• Support investigations and root cause analysis activities.
• Author and review SOPs and work instructions.
• Deliver GMP training and support employee development initiatives.
• Participate in quality improvement projects and operational excellence programs.
• Prepare weekly and monthly quality metrics.
• Maintain departmental performance boards and reporting tools.

Skills

Communication skills

Stakeholder management

Documentation and reporting

Data integrity

Education

MSc or BSc in Pharmaceutical/Life Sciences

Tools

GMP

GDP & GCP

Job description

The Company

A global organization within the pharmaceutical and life sciences sector focused on maintaining high quality standards in manufacturing and packaging operations. The company operates in a highly regulated environment where compliance, patient safety, and continuous improvement are key priorities.

Role Description

We are seeking a Quality Assurance Specialist to provide quality oversight and GMP support within a production environment. This role serves as a key quality partner to manufacturing teams, ensuring compliance with procedures, reviewing batch documentation, supporting investigations, and driving continuous improvement initiatives. The position requires close collaboration with production, engineering, warehouse, and quality teams while working in a rotating shift structure.

Responsibilities

• Provide QA guidance and support to production operations
• Review and approve batch production records before manufacturing activities begin
• Perform batch record reviews for assembled, packaged, and labeled products
• Conduct finished product quality checks during production runs
• Act as first point of contact for quality related production questions
• Perform GMP compliance checks within the manufacturing area
• Review, approve, and manage deviation records
• Initiate and own quality deviations when required
• Support investigations and root cause analysis activities
• Author and review SOPs and work instructions
• Deliver GMP training and support employee development initiatives
• Participate in quality improvement projects and operational excellence programs
• Prepare weekly and monthly quality metrics
• Maintain departmental performance boards and reporting tools
• Build strong relationships across Production, Engineering, Maintenance, Warehouse, and Quality teams

Requirements

• MSc or BSc degree in Pharmaceutical Sciences, Life Sciences, or a related discipline
• Minimum 3 years of Quality Assurance or pharmaceutical manufacturing experience
• Experience with batch record review and investigations
• Strong understanding of GMP regulations
• Knowledge of GDP and GCP principles
• Experience working within pharmaceutical or medical device environments
• Familiarity with manufacturing and quality processes
• Strong communication and stakeholder management skills
• Experience identifying and resolving data integrity issues
• Fluent English communication skills
• Ability to train and guide colleagues
• Strong documentation and reporting capabilities

Other Information

The role will initially operate on a 3-shift schedule, but candidates must be flexible and willing to transition to a 5-shift schedule at a later stage

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