Technical Product Complaint Support Specialist
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 Technical Product Complaint Support Specialist, you will be responsible for:
- Collecting and verifying relevant complaint information from batch records, electronic systems, and available product or distribution data.
- Ensuring complete, accurate, and timely documentation of complaint records in TrackWise.
- Performing the initial assessment and classification of 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 batch documentation and historical data to support the identification of potential complaint causes.
- Processing complaints where no sample is available, using batch records, historical data, and technical information.
- Handling cases with unknown batch information by assessing available evidence and seeking expert support where required.
- 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, knowledge sharing, and the continuous improvement of complaint-handling activities.
About our future employee
You should speak English at a minimum B2 level. Knowledge of German is an advantage. You should also bring 2-4 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 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.