Csv Consultant - Durham, United Kingdom - PM Group

PM Group

Verified Company

Durham, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

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PM Group is looking for a CSV consultant to support a pharmaceutical project in the North East
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Responsibilities

Generation and execution of validation protocols and reports (including IQs, OQs, PQs, QAPs, etc.).
Generation and execution of Functional & Configuration specifications.
Generation and execution of URSs.
Generation and execution of UAT.
Generation and execution of executing Data Migration documents.
Generation of Traceability matrix.
Generation of reports.
Drafting SOP.
Requirement analysis and process rationalization.
Carrying out CSV actions relating to laboratory equipment and small scale process equipment.
Leading CSV decisions, determining CSV requirements, advising the business on CSV practices, sharing CSV knowledge with the team.
Validating the introduction of new systems and providing data integrity risk assessments for each.
User requirement specifications
Creating design specifications
Creating functional specifications
Documentation creation and approval
Data management tasks, e.g. importing records, sample checking, etc
Supporting preparation of computerised system documents, validations plans, risk assessments and qualification protocols
Designing, generating and executing test plans and test protocols
Project delivery reporting
Working within a clientled team to deliver a key client project
Stakeholder management