Senior Quality Assurance Specialist

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

Role: Production Expert III/Senior Quality Assurance Specialist

Duration: 3 Months from Start

Fully onsite position.

Required:

• Bachelor’s degree with several years of relevant work experience or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, Life Sciences, or a related field.
• Experience in the pharmaceutical industry, preferably within a production/manufacturing environment.

Description:

As a Senior Quality Assurance Specialist, you play a key role in ensuring the quality, compliance, and continuity of pharmaceutical production. You support production teams with quality-related issues, investigate deviations, drive corrective and preventive actions, and ensure compliance with GMP requirements. You work closely with Production, QA, QPs, Process Teams, and other stakeholders to maintain and continuously improve pharmaceutical manufacturing processes.

Key responsibilities:

• Quality Assurance & Production Support
• Support pharmaceutical 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 and document root cause investigations.
• Develop, implement, and follow up on CAPAs.
• Support compliance investigations and responses to audit observations.
• Identify and implement improvements to production methods, products, processes, and technologies.
• Support improvement initiatives resulting from deviations, audits, and continuous improvement activities.
• Participate in quality-related projects and production optimization initiatives.
• GMP & Documentation
• Review SOPs, production protocols, validation protocols, Batch Manufacturing Records (BMRs), and other GMP documentation.
• Ensure compliance with company quality standards, GMP instructions, and documentation requirements.
• Participate in change controls, CAPAs, validation activities, and other quality initiatives.
• Provide knowledge transfer, training, and technical guidance to production personnel.

Key requirements:

• Strong knowledge of GMP and pharmaceutical production processes, preferably including aseptic manufacturing.
• 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.
• Strong analytical, problem-solving, communication, advisory, and reporting skills.
• Ability to work effectively in a dynamic and demanding manufacturing environment.
• Strong collaboration and stakeholder management skills.
• Excellent written and spoken English.
• Quality-oriented, results-driven, and technically strong mindset.