*********** CSV Consultant - 8 month contract - Prague/remote ************
On behalf of an international client, RED now has an exciting new opportunity for an experienced CSV (Computer Systems Validation) consultant for an initial 8 month contract with a long term scope.
You need to have at least 6+ years experience with IT Quality Assurance with specialisation in Computer Systems Validation (CSV). In addition, besides being quality oriented, you need to also be process oriented in order to guide the business to develop solutions to improve their CSV processes. Fluent English language skills are required.
Specific skills/experience needed:
- 6+ years of IT Quality Assurance experience with specialisation in Computer System Validation (CSV).
- Experience in Risk & Compliance management; GxP regulations, FDA, Annex 11 and ISO standards is needed.
- Pharmaceutical industry experience is a must.
- You will be working on a global SAP implementation project
- You will be responsible for maintaining high level quality solutions and services within the IT organisation
- Implementation and monitoring of controls described in the IT policies and procedures.
- Review and approve project deliverables (e.g. Validation plans, test plans) to ensure alignment with the Quality management system and regulatory requirements
- Coordinate with users to adhere to project plans and key project quality milestones
- Typical quality, risk and compliance areas include GxP regulatory compliance (computer systems validation)
- Must have excellent communication skills and be solution oriented in order to provide guidance to the Stakeholders.
Primary work location will be Prague with occasional travel. Large degrees of remote work is a possibility after initial on-boarding phase.
If you are interested, please apply here or send your updated CV to Alex Upton-Agerholm on firstname.lastname@example.org