QA Production Specialist

SIRE LIFE SCIENCES; Haarlem; On-site; EUR 60,000 - 80,000; Full time

Job summary

SIRE LIFE SCIENCES in the Netherlands is seeking a QA Production Specialist to support pharmaceutical production (bulk manufacturing and packaging) and lead deviations and CAPAs. You will review GMP documentation, participate in audits, and drive continuous improvement while collaborating with QA, Engineering and Production teams.

Strong English communication and a quality-focused mindset are essential. This role offers a dynamic production environment and opportunities to impact product safety

Qualifications

• Master's degree or equivalent in a relevant field.
• Experience in the pharmaceutical industry and production environment.
• Knowledge of GMP and QA systems.
• Experience with deviations, root cause investigations and CAPAs.
• Experience reviewing GMP documentation (SOPs, BMRs, validation protocols).
• Strong analytical, advisory, communication and reporting skills.
• Excellent spoken and written English.
• Ability to work in a dynamic production environment.

Responsibilities

• Provide QA support to pharmaceutical production, including bulk manufacturing and packaging.
• Support production teams with deviations, quality issues and compliance questions.
• Assess deviations and advise whether production activities should be halted when required.
• Investigate and document deviations, complaints, root causes and CAPAs.
• Monitor production processes and identify deviations from procedures.
• Review SOPs, validation protocols, BMRs and other GMP documentation.
• Participate in change controls, CAPAs, audits and investigations.
• Develop and implement continuous quality improvement initiatives.
• Provide recommendations regarding product safety, occupational health and environmental matters.
• Deliver training and knowledge transfer with stakeholders.

Skills

GMP knowledge

Root cause analysis

CAPA management

SOP review

Validation protocols

Analytical skills

English communication

Education

Master's degree in Pharmacy/Chemical Engineering

Job description

About the Company

Our client is an international pharmaceutical organization focused on the development and production of high-quality medicines. Within a regulated production environment, the organization places strong emphasis on GMP compliance, quality assurance, continuous improvement and patient safety.

Role Description

As a QA Production Specialist, you will provide quality assurance support to pharmaceutical production, covering both bulk manufacturing and packaging activities. You will support production teams with deviations and quality issues, lead or contribute to root cause investigations and CAPAs, and assess the impact of deviations on production activities. You will also review GMP documentation, support audits and compliance investigations, contribute to improvement projects and provide quality-related training and knowledge transfer within the organization.

Key Responsibilities

• Provide QA support to pharmaceutical production, including bulk manufacturing and packaging.
• Support production teams with deviations, quality issues and compliance questions.
• Assess deviations and advise whether production activities should be halted when required.
• Investigate and document deviations, complaints, root causes and CAPAs.
• Monitor production processes and identify deviations from established procedures.
• Review SOPs, validation protocols, BMRs and other GMP documentation.
• Participate in change controls, CAPAs, audits and compliance investigations.
• Develop and implement continuous improvement and quality improvement initiatives.
• Provide recommendations regarding product safety, occupational health and environmental matters.
• Deliver training and knowledge transfer and collaborate with Production, QA, QPs, Engineering and other stakeholders.

Requirements

• Master's degree or equivalent academic working level, preferably in Pharmacy, Chemical Engineering or a related field.
• Experience within the pharmaceutical industry and production environment.
• Knowledge of (aseptic) pharmaceutical processes and production control systems.
• Strong knowledge of GMP and Quality Assurance systems.
• Experience with deviations, root cause investigations and CAPAs.
• Experience reviewing SOPs, BMRs, validation protocols and GMP documentation.
• Strong analytical, advisory, communication and reporting skills.
• Excellent command of spoken and written English.
• Ability to work effectively in a dynamic and demanding production environment.
• Strong quality-oriented, collaborative and results-driven mindset.

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