Description
We are looking for a manager of IT compliance for a mid-size pharmaceutical compnay in San Francisco. This company currently has commercial drugs in the EU and Canada, with the goal of going commercial by 2014 here in the US. This position requires someone who has good knowledge of hands on IT validation, but is now ready to oversee it from a QA perspective.Essential Job Functions
- Establish the validation strategies and plans for GxP computer systems and ensure the validation deliverables for computer systems meet the internal quality standards and external health authority requirements, e.g., FDA, European Medicines Agency
- Develop validation strategy for GxP projects, including resource requirements and schedule; lead validation teams
- Lead and document computerized system risk assessments.
- Create and/or review validation documentation such as Validation Plan, URS, Functional Requirements, Design Documents, IQ/OQ/PQ and associated test scripts, and Validation Summary Packages.
- Review computer system change requests and perform impact assessments.
- Participate in issue investigation and associated CAPA identification, management, and resolution.
- Support various initiatives to enhance the IT Quality, Security and Compliance capabilities of the organization, e.g., improve policies, procedures, measures and skills
- Work closely with IT Team members to provide guidance and advocacy of QS policies, processes and toolset and support QS awareness and training program
- Participate in software vendor management (software as a service), including input to the Quality Agreement, reviewing vendor deliverables, and resolving compliance gaps identified at the vendor.
- Identify exceptions associated with validation protocol execution and system maintenance and follow issue resolution procedures.
- Information technology and/or pharmaceutical industry experience with exposure to a broad range of GxP validation activities such as document control, computer systems, vendor assessment, and change control.
- 5 years experience performing testing and system validation work in a GXP environment
- Must possess excellent technical writing, documentation and communication skills
- Experience with managing a validation team of onshore/offshore service providers
- Knowledge of FDA requirements for computerized systems, including experience interpreting 21 CFR Part 11 and EU GMP Annex 11 requirements
To find out more about Real please visit www.realstaffing.com