CSV Expert Senior GPvP
CSV Expert Senior GPvP
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Job Description
The Senior CSV will act as a deputy for the IT Compliance Lead and coach for junior resources and other stakeholders
Lead and execute validation activities and deliverables on assigned Changes and Projects
Proactively identify in alignment with the IT Compliance Lead the validation approach and deliverable list.
Responsible for authoring facilitating reviewing any CSV deliverable as per the RACI matrix: authors amongst others: Validation requirement assessment Validation Plan and Report Test protocols and report Traceability matrix. Facilitate all other deliverables
Responsible for the sequencing and monitoring of deliverable completion
Endtoend ownership and followingup proactively on validation documentation and testing activities
Coordinate test in collaboration with IT system owner Business Owner and testing team
Create test protocols and report (IQ/OQ/PQ/MQ)
Support the writing and of test scripts (IQ/OQ/PQ/MQ) with IT and business stakeholders
Creates facilitates and monitor Deviations and related actions (investigations CAPA
Escalate any issues or delay to the IT Compliance Lead
Be fully available and committed during an Inspection/Audit preparation and defense
Be the deputy of IT Compliance Lead for project assigned and share validation status with project team
Direct report to the IT Compliance Lead on personal activities via weekly meeting
Be part of a weekly activities review meeting with associated IT Compliance Lead
Coach junior CSV resources and other stakeholders on CSV and Compliance activities
Requirements
Job Qualifications:
Bachelor degree in pharmarelated domain or ITrelated domains
Specific Skills:
Good experience working and handling CSV Projects minimum 8 years.
Diplomatic good communication and negotiation skills.
Good English speaking/writing skills French speaker would be a plus.
Stakeholder management.
Proactive and motivated. Dynamic and Handson
Able to work in autonomous mode.
Strong analytical and problemsolving skills
Ability to work in a fastpaced operational environment and successfully prioritize important tasks
Domain Skills
General Pharma application
o GPVP eg adverse event reporting (Argus ArisG Veeva Safety)
o GCP eg. Clinical trail monitoring (CTMS..
o General Pharma applications and Veeva knowledge
Employment Type
Full Time
