Quality Associate, Product Complaints
- The biggest part of your job is coordinating complaints and sample handling. This will be the processing of incoming cases and responding to complaint originator queries in addition to managing the team E-mail inbox. You review incoming cases, ensuring global consistency and compliance.
- You are responsible for quality management system processes and will initiating continuous improvement projects at a local or global level to address issues and resolutions. This also entails writing, reviewing and evaluating SOP's concerning the complaints against regulations and global procedures and directives .
- You perform data analyses and carry out metric reporting including those related to assigned CMOs, partners, supplier review meetings and audits. Based upon this you communicate data trends and critical cases to impacted groups and managers.
- You are excellent in building strong relationships with both internal- and external stakeholders. You deliver external training being responsible for the content so that specific needs dependent on market, affiliates or distributors are met. You deliver also internal training being responsible for the content managing updates for both global and local process requirements. You will ensure the quality and performance of internal and external stakeholders by looking at KPI's.
- You are responsible for lab and sample investigations. You perform sample evaluation as per procedure and support the creation of investigation method. You manage the internal or external lab under management supervision and ensure the processes comply to SOP's and GMP standards.
- A first working experience in a quality or technical product complaint function.
- Proficient in Word, Excel, PowerPoint.
- Fluent English (written and spoken) is a must
- GMP knowledge
As a Quality expert in Biogen’s Technical Product Complaint department you are responsible for product related customer complaints. You ensure compliance with regulatory standards for the markets in which the companies products are manufactured and distributed.
In addition you lead projects when needed and initiate and implement changes and improvements with the support of the management. You will be part of a team of 7 people and report to the manager of Product Complaints.