CSV Analyst - 12 Month FTC

Huntingdon, United Kingdom
18 Sep 2019
18 Oct 2019
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Covance has an exciting opportunity for an experienced CSV Analyst on a 12 month maternity contract for an internationally recognised organisation.Covance provides mission-critical products and research services for pharmaceutical, crop protection, and chemical companies as well as universities, governments, and other research organizations.At Covance, we are working together to build a healthier and safer world, we exist to help our customers secure the potential of their research and develop products that enhance and enrich life.

It\u2019s an exciting time to join ourteam in IT Systems Compliance at our site in Huntingdon. We arelooking for a CSV Analyst to join our successful and growing team. Your core responsibilities will include the validation of computerised systems in a GxP environment and the development and delivery of CSV documentation including Risk Assessments, Validation Plans, User Requirements Specifications, Installation, Operational, and Performance Qualification Test Protocols, Traceability Matrices, and Summary Reports.

Additional responsibilities will include:
  • Leading projects on behalf of the business in accordance with defined methods and standards, according to applicable regulatory guidelines (OECD 17, FDA, EU Annex 11, PICs, MHRA Data Integrity etc ).
  • Identifying regulatory compliance risks and proactively work with the business and IT to address them
  • Developing, or overseeing the preparation of, key validation deliverables (User Requirements Specifications, Validation Master Plan, IQ, OQ, PQ, Validation Summary Report, etc)
  • Supporting and maintaining validation / qualification state of existing systems through Change Control
  • Performing Vendor Audits and site assessments
  • Working with project managers and team members to define project plans, timescales and budgets.
  • Assisting with developing Standard Operating Procedures in support of CSV and regulatory compliance (Information Systems Security, User Application Permissions, User Access & Administration, Disaster Recovery, System Administration, etc)
  • Maintaining knowledge and developing greater understanding of system development and validation activities with a GxP environment.
  • Supporting corporate quality and improvement processes.
Proven experience working in a Pharmaceutical, Chemical, biotech or other highly regulated industry.
We\u2019re looking for someone with:
  • Proven experience working in a Pharmaceutical, Chemical, biotech or other highly regulated industry.
  • Good understanding of system compliance regulatory requirements and guidelines (OECD 17, FDA, EU Annex 11, PICs, MHRA Data Integrity etc )
  • Exposure to / working knowledge of systems such as Laboratory Systems (e.g. Empower, Analyst, EMKA), LIMS (e.g. Pristima, Labware, Debra), Document Management Systems (e.g. Documentum, SharePoint).
  • Proficiency in both verbal and written communications and possess a high degree of personal integrity and interpersonal skills
  • Leadership and teamwork skills
  • Strong problem solving, analytical, technical acumen and organizational skills

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