Process Validation Manager

I have a great opportunity for a Process Validation Manager in the Los Angeles area with a well established Pharmaceutical company. They are looking for someone with experience in the following,

Essential Duties and Responsibilities:

* Is a key Leadership position within the Validation department and must be capable of high-level project leadership.
* Creates and is responsible for the Process Validation program. The PV program must be designed to meet expectations in accordance with FDA/ICH regulations/guidance.
* Will create, develop, and implement the SHC Process Validation program and written plan using the 2011 FDA Process Validation Guidance.
* Provides hands on support and technical project management in the development, execution, and maintenance of the Process Validation program, with support from the Manufacturing, Quality Control, Quality Assurance, Quality Systems, and Technical Affairs departments.
* Creates and/or leads the development of the Process Validation Master Plan. Identifies support plans (e.g., product characterizations, manufacturing scale characterization studies, mixing validation, etc.) required to execute Process Validation deliverables.
* Supports the development of Process Verification programs with associated analyses and reports.
* Responsible for ensuring creation, review, and approval of process characterization study and validation protocols and reports.
* Assists in the integration of Process Validation process(s) at contract manufacturing sites.

* Capable of delivering presentations to high level leadership, clients, and regulatory inspectors.
* Is the Process Validation Subject Matter Expert (SME) for regulatory inspections and other audits.

Education and/or Experience:

* Bachelor's degree in Engineering, Biology, or Chemistry is the minimum qualification or equivalent combination of experience, training and/or education. An advanced degree is a plus.
* Minimum of 5+ years of relevant validation experience, process validation preferred.

* Good working knowledge and understanding of pharmaceutical manufacturing equipment and associated processes.

This is an urgent position so send your resume in ASAP to be considered for a interview.
To find out more about Real please visit www.realstaffing.com