Senior Csv Consultant
hace 4 días
**Senior CSV Consultant**:
- Location:
Zaragoza, Spain
- Contact:
Paula Maguillo
- Job type:
Contract
- Industry:
Pharmaceutical
**Exciting Opportunity: Senior CSV Consultant in the Pharma Sector**
We are thrilled to announce an incredible opportunity for a Senior CSV Consultant in the pharmaceutical sector. Our client a top leading pharmaceutical company is currently living an expanding moment with a new facility and Oxford is hiring dynamic individual to join our team.
Capability to work in GxP environment to provide leadership and in-depth expertise in ensuring that all computerized systems used in pharmaceutical operations are validated and compliant with local, regional, global regulations (GAMP5, 21 CFR part 11 and Annex 11) and company standards. Drive the strategy about CSV projects and processes. Capability to interact with different supplier to define a strategy to leverage supplier's documentation within the validation project.
**Responsibilities**:
- Plan, lead, and execute advanced validation activities for complex computerized systems.
- Draft, review, and approve high-level validation documentation and provide guidance to junior team members in their drafting processes.
- Collaborate business, IT and engineering teams to define strategy on system requirements and validation methodologies.
- Lead and provide insight on the Risk Assessment process.
- Provides strategic advice to the client with consideration of the industries regulations and requirements.
- Provides the client with strategic advice on organizational design.
- Performs GxP audits, compliance assessments of information systems, integrated manufacturing systems and IT infrastructures per the GAMP 5 approach and company's SOPs.
- Identifies development opportunities in regards of the Computerized System Validation
- Leads and if necessary, conducts operational support in regards of the Computerized System Validation.
**Requirements**:
- Bachelor or Master degree in IT, Life Sciences or comparable
- Professional level of verbal and writing skills (English and spanish)
- Knowledge of regulations, quality standards and a GxP mindset
- A minimum of 8 years of experience with CSV and compliance, in life science industry or an industry with a comparable high regulatory level, is required.
- Competent in MS Office products and experience with Quality Systems
_ We look forward to welcoming a passionate and skilled individual to our team_
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