Senior Quality Investigator

SIRE LIFE SCIENCES; Haarlem; On-site; EUR 55,000 - 85,000; Full time

Job summary

SIRE LIFE SCIENCES in Haarlem is seeking a Quality Investigations Specialist to manage deviation records, conduct GMP-compliant investigations, and drive CAPAs within a fast-paced production environment. The role emphasizes rigorous root cause analysis and strong documentation.

You will collaborate with QA, Production, QPs, Technicians and Process Leads to review SOPs, validation protocols and batch records, ensuring timely closure of quality events and ongoing compliance with GMP requirements.

Qualifications

• Minimum 3 years of pharmaceutical industry experience.
• Experience managing deviations and investigations.
• Strong understanding of pharmaceutical quality systems.
• Proven root cause analysis experience.
• Experience developing and implementing CAPAs.

Responsibilities

• Write, review, and manage deviation records
• Conduct quality investigations within GMP environments
• Perform root cause analysis for production related deviations
• Develop and document CAPAs
• Drive investigations toward timely closure
• Support production teams with quality and compliance matters
• Assess the impact of deviations on manufacturing activities
• Review SOPs, validation protocols, and batch manufacturing records
• Monitor production processes and identify quality risks
• Support change controls, quality improvement projects, and audit responses
• Ensure compliance with quality systems and GMP requirements
• Participate in continuous improvement initiatives
• Provide quality related training and knowledge transfer
• Collaborate with QA, Production, QPs, Technicians, and Process Leads
• Support regulatory and compliance investigations

Skills

Quality investigations

Root cause analysis

CAPA development

GMP experience

Documentation

Education

Pharmacy

Pharmaceutical Sciences

Chemical Engineering

Job description

The Company

A leading global pharmaceutical manufacturing organization focused on producing high quality medicines within a highly regulated GMP environment. The business operates large scale production facilities and places strong emphasis on quality, compliance, continuous improvement, and patient safety. The organization is currently strengthening its quality investigation capabilities to support production operations and ensure timely closure of quality events and deviations.

Role description

This role focuses on managing pharmaceutical quality investigations and supporting production teams with deviation management activities. The successful candidate will work closely with manufacturing teams to investigate production related deviations, perform root cause analysis, drive CAPAs, and ensure investigations are completed according to GMP requirements. This is an excellent opportunity for someone with hands on pharmaceutical quality experience who can quickly contribute within a fast paced production environment and independently drive investigations to closure.

Responsibilities

• Write, review, and manage deviation records
• Conduct quality investigations within GMP environments
• Perform root cause analysis for production related deviations
• Develop and document CAPAs
• Drive investigations toward timely closure
• Support production teams with quality and compliance matters
• Assess the impact of deviations on manufacturing activities
• Review SOPs, validation protocols, and batch manufacturing records
• Monitor production processes and identify quality risks
• Support change controls, quality improvement projects, and audit responses
• Ensure compliance with quality systems and GMP requirements
• Participate in continuous improvement initiatives
• Provide quality related training and knowledge transfer
• Collaborate with QA, Production, QPs, Technicians, and Process Leads
• Support regulatory and compliance investigations

Requirements

• Minimum 3 years of pharmaceutical industry experience
• Experience managing deviations and investigations
• Strong understanding of pharmaceutical quality systems
• Proven root cause analysis experience
• Experience developing and implementing CAPAs
• Academic degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, or a related discipline
• Experience in GMP regulated manufacturing environments
• Ability to independently drive investigations to completion
• Strong analytical and problem solving skills
• Excellent written and verbal English communication skills
• Strong documentation and technical writing abilities
• Experience within pharmaceutical production environments