GMP & CAPA QA Specialist

SIRE LIFE SCIENCES

Haarlem

On-site

EUR 65,000 - 90,000

Full time

3 days ago

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Job summary

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.

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.