Senior Specialist, Technical Product Complaints (GMP)

Boehringer Ingelheim Pharmaceuticals, Inc.; Wrocław; Hybrid; PLN 90,000 - 130,000; Full time

Job summary

Boehringer Ingelheim Pharmaceuticals, Inc. in Wroclaw seeks a Senior Specialist Technical Product Complaint Support to manage end-to-end technical product complaints, data collection, initial assessment, and compliant documentation. You will coordinate investigations across Production, QC and Technical Services in a global setting.

The role requires 4–6 years in GMP environments, English at least B2, and a strong analytical mindset with a focus on quality and regulatory compliance.

Qualifications

• 4–6 years of experience in pharma manufacturing, quality control, or GMP environments.
• English at least B2; German is advantageous.
• Knowledge of GMP regulatory requirements and internal procedures.
• Experience with electronic documentation or quality management systems; TrackWise, SAP or PAS-X is a strong advantage.

Responsibilities

• Collect and verify complaint information from batch records and data sources.
• Document complaint records accurately and timely in TrackWise.
• Assess and classify complex technical product complaints and initiate investigations.
• Coordinate investigations with Production, QC, and Technical Services.
• Analyze cases to identify root causes and potential defects.
• Manage complaints with limited information and ensure timelines.
• Escalate when needed and coordinate with experts across functions.
• Ensure GMP compliance and adherence to regulatory standards.

Skills

Analytical thinking

GMP knowledge

Cross-functional collaboration

Quality compliance

Documentation

English communication

Education

Bachelor's degree in Pharmacy

Tools

TrackWise

SAP

PAS-X

Job description

Boehringer Ingelheim Pharmaceuticals, Inc. in Wroclaw seeks a Senior Specialist Technical Product Complaint Support to manage end-to-end technical product complaints, data collection, initial assessment, and compliant documentation. You will coordinate investigations across Production, QC and Technical Services in a global setting.

The role requires 4–6 years in GMP environments, English at least B2, and a strong analytical mindset with a focus on quality and regulatory compliance.