Computer Systems Validation Senior Lead

COMPUTER SERVICE VALIDATION, TECH BASED CELL & GENE SERVICE PLATFORM, LONDON, PERMANENT

Headquartered in London, this new Client of ours is working at the forefront of their functional area, playing a critical role in creating pragmatic software solutions for cell therapy manufacturers. Using smart technology, they are driven to make this highly-specialised area of medicine deliverable, available and affordable, enabling ATMP Manufacturers to bring autologous medicines to more patients. They have asked me to identify their next Computer Service Validation Consultant to join their fast-moving, value-orientated start up as they look to revolutionise autologous medicines and accessibility to them.

Working with specialists in their functional area, your primary role will be to ensure that all Validation documentation and related processes, procedures and systems meet the requirements of MHRA/ FDA regulations. Using your experience and knowledge of GAMP5 regulations, Annex 11 and CFR Part 11, you will ensure computer systems, including a variety of ERP based systems and Laboratory systems within a GMP environment, are validated in a timely manner. You will be working on projects that include networking standalone systems, and the addition of new instruments to ensure they are compliant to GAMP5 and regulatory guidelines. If you enjoy being faced with technical challenges and having decision-making power as a centralised member of a team with an exciting mission, this is the ideal role for you.

To thrive in this role, you must have:

• Relevant degree in a Scientific or Technical discipline
• Proven industry experience in a CSV role within the pharmaceutical industry following GAMP5 methodology
• Working knowledge and practical experience with CSV for laboratory and ERP based systems
• Basic understanding of blockchain technology

If playing a pivotal role in bettering the delivery of cellular medicines on behalf of an ambitious, ever-growing company with a proud culture of fostering the very best talent in the market excites you, please do not hesitate to contact Recruitment Consultant James Fitzjohn on +44 (0)20 3907 1988, or email him at jfitzjohn@i-pharmconsulting.com. If this role is not suitable, James is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

i‐Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i‐Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Biometrics.

KEY WORDS:

CAPA / QMS / Audit / Auditor / GxP / GCP / GMP / GLP / GDP / GDPR / SOP / Cleaning / Validation / CSV / Computer Service Validation/ Computer Systems Validation/ Equipment / Manufacture / Manufacturing / Facility / Utilities / Machinery / ERP/ Enterprise Resource Planning / FDA / GAMP / MHRA / HVAC / CFR 21 / Annex II / Annex 15 / Medical Device / Sterile / Wet / Non-wet / Dry / Non Wet / Biologics / Microbiology / Microbiologist / IQ / OQ / PQ / cGMP / Author / SOP writing / SOP / SAE / Quality Assurance / QA / QA specialist / Compliance / V-Model / Manager / Leader / QC / Quality Assurance / Quality Control / Senior Manager / Senior Management / Pharmaceutical / Quality Engineer / QA Engineer / Validation Engineer / Biotechnology / NCR / CAPA / London / Kent / Hertfordshire / Surrey / Middlesex / Essex / Watford