7 GMP Jobs in Stevenage

GCLP, CLIA, CAP, ISO15189 laboratory requirements Experience in CLSI, NYDOH and other industry standards for assay validation; Understanding of IVD regulations including QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do more »

experience leading IT at a senior management level Track record of delivering results quickly Experience in delivering IT services to customers Work in a GMP or highly regulated environment Preferred Experience: Experience of agile product development Experience of Lean Six Sigma Infrastructure delivery (networking, hardware) to customers Experience with data more »

renowned for their commitment to excellence. Role Overview: As a Senior Project Manager, you will oversee the entire project lifecycle, focusing on Grade C GMP cleanrooms for this Micro Bio Pharma facility. From initial feasibility to full construction, commissioning, and qualification, you will ensure projects meet the highest standards of more »

and operational support OR 3+ years in a similar role with Manufacturing OT equipment, in Healthcare/Pharma. 3+ years working with GxP and GMP environments. If you're interested and would like to find out more, reach out on LinkedIn or send your CV to lauren.mckinley@skillsalliance.com. more »

within a multi-disciplinary team to take a tactical role in the design, implementation, and establishment of suitable governance processes to assure the consistent GMP compliance of the CGT Catapult Stevenage GMP facility for cell and gene therapy. Participate in the preparation for and the management of regulatory agency and … and support the evolution of the quality culture throughout CGT Catapult and to train employees in quality related activities where appropriate. Maintain processes, including GMP document control and training, needed for successful site compliance to the QMS. Participate in the review the performance of the QMS at planned intervals and … provide regular reporting to ensure its continuing suitability, adequacy and effectiveness and propose improvements. Participate in the execution of a GMP internal audit programme including the identification and implementation of appropriate corrective actions and a process to track their completion. Experience: Demonstrable experience in an Operational Quality Assurance role providing more »

Comfortable operating autonomously once goals and objectives are set. Excellent interpersonal, written and verbal communication skills. Confidence and ambition to provide pragmatic and considered GMP advice. Having current and up to date professional knowledge, expertise and best practice. Proven ability to engage constructively with colleagues at all levels across different more »

implement software solutions for all aspects of the products. They will assist software development within the team, ensuring best practices to medical device and GMP standards where appropriate. The software engineer at MFX will be a key player in advancing the revolutionary bioprocessing platform for the Cell and Gene Therapy …/hardware interfaces, user interfaces, data logging and presentation. Work with the existing software development team. Follow all relevant medical device directives and EU GMP Annex 11 with regards to software. Keep relevant Quality Management System documentation up to date. Qualifications & Experience: 2+ years of experience creating software for a more »