Quality Assurance Specialist

SIRE LIFE SCIENCES; Haarlem; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

SIRE LIFE SCIENCES is seeking a Quality Assurance professional to support and maintain QA activities in pharmaceutical manufacturing, ensuring GMP compliance and driving CAPA efforts. You will investigate deviations, review batch records, and collaborate with production teams to improve quality systems.

The role requires a Master's degree in a related field, strong English communication, and experience in pharmaceutical manufacturing environments.

Qualifications

• Master's degree or equivalent required.
• Degree in Pharmacy, Chemical Engineering, Life Sciences or related field.
• Experience in pharmaceutical manufacturing environments.
• Knowledge of GMP regulations and quality systems.
• Experience with deviation management, investigations and CAPA processes.
• Excellent written and verbal English communication.
• Strong analytical and problem-solving skills.
• Able to work in a fast-paced environment.
• Experience reviewing manufacturing and validation documentation.

Responsabilités

• Write and manage production deviations and quality events.
• Monitor manufacturing processes and identify deviations from established procedures.
• Investigate quality issues, complaints, and non-conformances.
• Perform root cause analysis and develop CAPA plans.
• Support compliance investigations and quality improvement initiatives.
• Review SOPs, validation protocols, production documentation, and batch manufacturing records.
• Ensure compliance with GMP and company quality standards.
• Recommend improvements related to product quality, safety, health, and environmental standards.
• Participate in cross-functional quality and compliance projects.
• Provide quality related guidance and support to manufacturing teams.
• Maintain accurate documentation and reporting of quality activities.

Connaissances

Analytical skills

Problem-solving

Communication (English)

Organizational skills

Time management

Formation

Master's degree or equivalent

Degree in Pharmacy / Chemical Engineering / Life Sciences or related

Outils

Production control systems

Description du poste

The Company

A leading pharmaceutical manufacturing organization focused on producing high quality medicines in a highly regulated environment. The company emphasizes quality, compliance, continuous improvement, and operational excellence across its production activities.

About the Role

This role is responsible for supporting and maintaining quality assurance activities within pharmaceutical manufacturing operations. The position focuses on ensuring GMP compliance, investigating deviations, driving CAPA initiatives, and supporting continuous improvement efforts. The successful candidate will work closely with production teams to enhance quality systems and maintain regulatory standards.

Responsibilities

• Write and manage production deviations and quality events
• Monitor manufacturing processes and identify deviations from established procedures
• Investigate quality issues, complaints, and non-conformances
• Perform root cause analysis and develop CAPA plans
• Support compliance investigations and quality improvement initiatives
• Review SOPs, validation protocols, production documentation, and batch manufacturing records
• Ensure compliance with GMP and company quality standards
• Recommend improvements related to product quality, safety, health, and environmental standards
• Participate in cross-functional quality and compliance projects
• Provide quality related guidance and support to manufacturing teams
• Maintain accurate documentation and reporting of quality activities

Requirements

• Master's degree or equivalent academic level
• Degree in Pharmacy, Chemical Engineering, Life Sciences, or a related discipline
• Experience in pharmaceutical manufacturing environments
• Knowledge of aseptic pharmaceutical processes
• Understanding of GMP regulations and quality systems
• Experience with deviation management, investigations, and CAPA processes
• Familiarity with production control systems
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills in English
• Strong organizational and planning abilities
• Ability to work effectively in a fast-paced environment
• Experience reviewing manufacturing and validation documentation

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