Senior Specialist Technical Product Complaint Support

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

Senior Specialist Technical Product Complaint Support

The position

Are you looking for a role where you can combine technical understanding of pharmaceutical products with analytical problem solving, quality compliance and cross-functional collaboration? Join our team in GBS Wroclaw and support the end-to-end handling of technical product complaints, from complaint intake and data collection through initial assessment, investigation coordination and compliant documentation.

Tasks & responsibilities

As a Senior Specialist Technical Product Complaint Support, you will be responsible for:

• Collecting and verifying relevant complaint information from batch records, electronic systems, and available product and distribution data.
• Ensuring complete, accurate, and timely documentation of complaint records in TrackWise.
• Assessing and classifying complex technical product complaints based on available information, potential defects, and possible impact on patient safety.
• Initiating and assigning investigations to the appropriate functions, including Production, Quality Control, and Technical Services.
• Analyzing complex cases, batch documentation, and historical data to identify potential root causes of complaints.
• Managing complaints with limited information, including cases where no sample or batch information is available.
• Identifying cases requiring escalation and coordinating with relevant expert functions.
• Monitoring complaint records and ensuring they are processed within defined timelines.
• Ensuring complaint-handling activities comply with GMP requirements, applicable regulatory standards, and internal SOPs.
• Collaborating with Quality, Production, Technical Services, and other stakeholders in an international environment.
• Contributing to process documentation and maintaining complaint-handling standards.
• Providing guidance and sharing knowledge with colleagues on complex complaint cases and processes.
• Identifying and driving improvements in complaint-handling processes, documentation, and systems.
• Providing specialist expertise for projects, testing, and training activities.

About our future employee

You should speak English at a minimum B2 level. Knowledge of German is an advantage. You should also bring 4-6 years of relevant professional experience in pharmaceutical manufacturing, quality control, complaint handling or another GMP-regulated environment.

Additionally, we are looking for:

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, Engineering, Life Sciences or a related field would be an asset.
• Knowledge of pharmaceutical manufacturing processes and/or quality control.
• Experience working in a GMP-regulated environment and applying regulatory requirements and internal procedures.
• Technical affinity for pharmaceutical products and/or medical devices.
• Ability to translate detailed complaint descriptions into a potential defect and appropriate classification.
• Ability to independently assess complex complaint cases and provide guidance to colleagues.
• Ability to review batch records and identify information relevant to potential complaint causes.
• Experience with electronic documentation or quality management systems; knowledge of TrackWise, SAP or PAS-X is a strong advantage.
• Strong analytical skills and attention to detail.
• Ability to organize work independently, manage priorities and meet defined timelines.
• Ownership, reliability and a quality-focused mindset.
• Collaborative approach and ability to work effectively with cross-functional stakeholders in an international environment.

At Boehringer Ingelheim, we are committed to fostering an inclusive workplace that values diversity in all its forms, including disability. Our accessible office environment and dedication to equal opportunities support every employee in reaching their full potential.