Stevenage, England, United Kingdom Hybrid / WFH Options
Workday
GCLP, CLIA, CAP, ISO15189 laboratory requirements Experience in CLSI, NYDOH and other industry standards for assay validation; Understanding of IVD regulations including QSR regulations, GMPmanufacturing, 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 »
and vision systems integrated within packaging equipment including interfaces with enterprise systems. Responsible for providing cGMP compliant control systems as per GAMP5 and EU GMP Annex 11. Key Experience Essential - Practical experience working within manufacturing and packaging environments Experience of the automation project lifecycle including design, configuration, implementation, testing, commissioning more »
activities. What you'll need to succeed Our client is looking for an individual with strong experience as a Quality Assurance Officer within a GMP Pharmaceutical/Cleanroom environment. Other key desirables include: Quality Management System activities and maintenance. Experience in participating in internal/external audits. Be able to 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 updating risk assessments and risk mitigation procedures. Train necessary staff in relevant fields related to technical compliance. Implement and deliver site quality and GMP compliance metrics: tracking and investigating consumer complaints, internal and external audit outcomes, and customer compliance. Deliver successful customer and external audits: completion of a gap more »
and improvement of the Quality Management System (QMS). Assure the compliance of all activities with Good Distribution Practice (GDP) and GoodManufacturingpractice (GMP) requirements. Responding to medical information enquiries from healthcare professionals, community pharmacies, patients, and wholesalers. Ensuring the completion of checks for new products; having the appropriate more »
Hoddesdon, Hertfordshire, South East, United Kingdom
PHARMARON UK LIMITED
focused Extremely safety conscious Helpful and responsive and committed to delivering the very best Team playing whilst proactive and a self-starter Desirable Requirements: GMPmanufacturing equipment Recognised formal qualification in secondary control discipline or equivalent experience in Control Systems Knowledge of high integrity PCS and PLC programming would be … Drug Discovery teams. In addition, a Formulation Development team was also recently established. The Hoddesdon site has state-of-the-art GoodManufacturingPractice (GMP) standard facilities for the development of Active Pharmaceutical Ingredients (API), Formulation Development (FD) and Process Chemistry (PC). We offer a competitive salary and a 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 »
responsibility will be to ensure that all materials are tested according to agreed specifications and procedures, in agreed time frames and in accordance to GMP and company guidelines. Other key responsibilities will include to: - Qualify, maintain and calibrate all laboratory equipment according to procedures. - Maintain all laboratory Quality Systems and … Assurance Performance Indicators. Your Background: You are required to have the following qualifications, skills and experience: - Knowledge of Quality Control, Quality Assurance, Quality Systems, GMP and basic understanding of manufacture and packaging of pharmaceutical products. - Stability testing experience - Hands-on HPLC experience - Good technical and scientific judgement. - Diplomatic, self-motivating … professional with problem solving and decision-making capabilities. - Basic understanding of GMP Guidelines and Regulations. Apply: For more information, or to apply for this QC Analyst position please contact Hannah Oakley on 01246 457711 or email hoakley@ckgroup.co.uk. Please quote job reference 56706 in all correspondence. It is essential that 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 »