QC Sr. Specialist
About this Role:
The QC department of our client, a vibrant and expanding pharmaceutical company operating on a distinctive drug delivery product platform, is in need of a qualified and motivated Quality Control, Sr. Specialist. The company is producing cutting-edge medical therapies.
The Senior Manager Quality Control position necessitates overseeing the complete QC department, which includes validation engineers, associates, and microbiologists, among others. The chosen applicant will be essential to making sure that our goods and services fulfill the highest industry standards for dependability and quality.
Responsibilities:
- Contributes to the IVD product quality oversight in accordance with national laws and regulations that may be relevant, as well as ISO 13485, ISO 9001, IVDR, and cGMP standards.
- Supervise the investigation of complaints and report the findings.
- Oversees the serological work done by the Quality Control/Product Surveillance Lab, such as the different IMD product studies.
- Collaborates closely with the manager or supervisor of technical support to guarantee that complaint testing is finished on time and that customers are informed.
- Assist with product release by assessing release tests and providing samples to authorities who have been notified.
- Upkeeps the quality management system within the relevant domain
- Serves as the Deputy Head of Regulatory Compliance
Qualifications:
- S. with ten or more years of experience in the sector, or MS with eight or more years of experience in quality control expertise in the highly regulated biotech or pharmaceutical industries
- direct experience in leadership and people management
