Job Title : GxP Systems Team lead
Summary : Are you looking to join a company that impacts variety of patients lives? Are you passionate about helping a wide range of people across the globe? My client is a global pharmaceutical company with over 40 FDA approved sterile injectable products, ranging from corticosteroids to diuretics. They are seeking someone who has experience working with TrackWise QMS and is looking to make positive changes to help improve the system. If you have experience with this system and are seeking a position that will be challenging yet impactful on the entire company, please do not hesitate to reach out!
The GxP Systems Team Lead will be responsible for :
- Performing Validation for new and existing computer systems.
- Develop design qualifications, functional requirements, user requirements, unit test scripts, UAT scripts validation plans and IQ/OQ/PQ.
- Support and maintain quality programs, policies, processes and procedures.
- Maintain GxP systems inventory log and update.
- Manage project and compliance related issues.
- Identify and implement opportunities for continuous improvement related to validation and other compliance practices/issues.
The Gxp Systems Team Lead should have the following requirements :
- Bachelor's Degree in Biology, Chemistry, Public Health or in Life Sciences.
- At least 7 years of experience working in the pharmaceutical or GxP environment.
- Strong knowledge of SDLC.
- Extensive knowledge of GAMP5
- Strong knowledge of GxP guidelines.
- Excellent organizational and communication skills.
If this sounds like something you would be interested in, please apply!