IM Compliance Analyst

IM Compliance Analyst
  • £44,000 - £46,000 per Annum
    ANNUM
  • Permanent
  • Oxfordshire, England, UK Oxfordshire GBR Ox14 4RX
Job Ref: 50218440
Sector: Other
Date Added: 12 January 2022

IM Analyst, IM Controls - Permanent

Salary: up to £44K

The client

Our Client are a multinational clinical-stage bio-pharmaceutical company with a focus on researching, developing, and manufacturing T-cell based therapeutics for cancer treatments. The company strive to develop pioneering treatments that aim to transform the way certain cancers are treated.

You

The IM Controls Analyst will be responsible for ensuring that the computerized systems implemented and maintained in compliance with GxPs and other applicable regulations. This role will support the global end-to-end IM Change Control process for UK systems You will be responsible for ensuring the IT environment are well managed using a defined risk-based process to ensure minimal disruption to IT systems and business process.

Your responsibilities

  • Enhance IM controls and proving training for staff, business systems and stakeholders
  • Ensuring the best practice of IM controls
  • Represent IM to support Quality and Compliance with regulatory audit activities
  • Ensure change requests meet all requirements to increase success factors, reduce risk and minimize the impact of change-related incidents on service quality
  • Providing IM Controls and Compliance, IM Chance Controls and IM Computer Systems Validation Support

Your skills/experience

  • Bachelor's degree in computer science, technology or related field required
  • Experience working with GxP regulations
  • Familiarity with GAMP and other approaches to System Development Life Cycles, CAPA
  • Strong working knowledge of the validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures
  • Demonstrable experience in Pharmaceutical or other relevent industry
  • Demonstrated experience with authoring IT CSV documents (e.g. URS, FRS, IQ, OQ)

Next steps

If you believe you have the desired skills and experience, please follow the link to apply and attach a copy of your up-to-date CV. If successful, a Consultant will be in touch to discuss the role in more detail.

Lorien Plc is acting as an Employment Agency in relation to this vacancy.

Lorien
11/02/2022 09:11:24
GBP 44000 46000 Annum
Contact Consultant:
Zara Halahan

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