CSV Analyst - 12 Month FTC
- Employer
- Labcorp
- Location
- Huntingdon, United Kingdom
- Salary
- Competitive
- Start date
- 18 Sep 2019
- Closing date
- 18 Oct 2019
View more
- Discipline
- Finance / Administration, Administration
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
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.
Experience:
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
Company
At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.
- Website
- https://careers.labcorp.com/global/en
- Location
-
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom
Get job alerts
Create a job alert and receive personalised job recommendations straight to your inbox.
Create alert