Senior QA Specialist - GMP & Production Excellence

LanceSoft Europe; Haarlem; On-site; EUR 67,000 - 89,000; Full time

Job summary

LanceSoft Europe is seeking a Production Expert III / Senior Quality Assurance Specialist for a 3-month onsite assignment in the Netherlands. You will support pharmaceutical production operations, review GMP documentation, and drive deviation investigations, CAPAs, and change controls to ensure compliant manufacturing.

You will collaborate with Production, QA, and Process Teams, monitor quality and process adherence, provide training, and contribute to continuous improvement initiatives in

Qualifications

• Strong knowledge of GMP and pharmaceutical production processes.
• Experience in pharmaceutical production and quality assurance.
• Experience with deviation management, root cause analysis, CAPA, change controls, and audit/compliance activities.
• Experience reviewing GMP documentation, SOPs, BMRs, production protocols, and validation documentation.

Responsibilities

• Quality Assurance & Production Support: support production activities, including bulk manufacturing and packaging.
• Provide quality guidance on production deviations and quality-related issues.
• Assess deviations and determine whether production activities should be stopped, adapted, or continued.
• Monitor production processes and compliance with established procedures.
• Deviation Management & Root Cause Investigations: investigate and document production deviations and complaints, conduct root cause investigations, and develop CAPAs.
• Support compliance investigations and responses to audit observations.
• Identify and implement improvements to production methods, products, processes, and technologies.
• Participate in change controls, CAPAs, validation activities, and other quality initiatives.
• Provide knowledge transfer, training, and technical guidance to production personnel.

Skills

GMP knowledge

Quality assurance

Analytical thinking

Documentation

English communication

Education

Bachelor’s degree in Pharmacy/related field

Master’s degree in Pharmacy/related field

Job description

LanceSoft Europe is seeking a Production Expert III / Senior Quality Assurance Specialist for a 3-month onsite assignment in the Netherlands. You will support pharmaceutical production operations, review GMP documentation, and drive deviation investigations, CAPAs, and change controls to ensure compliant manufacturing.

You will collaborate with Production, QA, and Process Teams, monitor quality and process adherence, provide training, and contribute to continuous improvement initiatives in