Validation SME 9/3/2016
JOB DESCRIPTIONAPPLY We are looking for VALIDATION SME for our client in PRINCETON, NJ
JOB TITLE: VALIDATION SME
JOB LOCATION: PRINCETON, NJ
JOB TYPE: CONTRACT - 12 MONTHS / CONTRACT TO HIRE / DIRECT HIRE
* 10+ years' Experience in Pharma / Life Sciences / R&D Domain
* Should have worked in Pharma Core Industries
* Should be the owner for all the Customer defense in the Pharma business, Should lead the Validation competency on the LS cOE.
* Strong Experience in CSV and Testing Practices.
* To work in client RFP's and own all CSV related activities.
* Excellent Communication (Written and Verbal).
* Excellent Customer Management Skills.
* Team Player
* Knowledge on Quality and Compliance in Regulated Environments.
* Knowledge of Drug Safety, LIMS, TrackWise(R) and Engg Tools used in Pharma - is desirable.
* Hands On Experience in authoring / reviewing SDLC/CSV activities.
* Developing validation/verification/migration strategies for software, data, mobility, hardware and/or business processes prior to release into a live environment per SDLC.
* Executing validation/verification/migration strategies per SDLC.
* Providing validation/verification training to stake holders as necessary.
* Managing relationships with key customers and stake holders to ensure the total validation/verification solution delivered to the customer meets/exceeds expectations.
* Managing off shore team/testers.
* Knowledge of MS Office Products, Quality Center / Tools, FTP, Data Transfer and Storage.
* Knowledge of Databases and PL/SQL
* Familiar with Risk Assessment and Mitigation.
* Familiar with SOX, FDA Guidelines, CFR Part 11, GxP Regulations.
* Prior experience handling Divestures and Mergers will be a PLUS.