Sr. Validation Manager

Validation Management Position

Job Summary

The Sr. Validation Manager will be responsible for managing, developing, and implementing validation protocols and analytical testing methods in a cGMP pharmaceutical manufacturing facility.

6-9 month contract position paying $80+ hourly DOE.

Position Requirements

* Develop and oversee the Quality training program to ensure GMP compliance and internal training requirements. Assist in training company employees on the principles of Quality and other Quality System elements.

* Meet ISO 9001 and FDA requirements, to maximize product quality, to minimize overall costs associated with quality deficiencies and activities and to minimize customer quality complaints.

* Ensure that SOPs, MOPs, validations and internal audits are reviewed, approved, put in place and completed in a timely manner.

* Administer the Corrective / Preventive Action (CAPA) System and Conflict Analysis and Resolution (ICAR) System.

* Develop and oversee validation activities for products, processes and facilities including validation for 21 CFR part 11 as needed for Medical Device customers.

* The tactical execution of all aspects of quality engineering associated with the new product development, closed loop corrective action (CLCA), internal audit and material review board (MRB) processes.

Basic Qualifications
* 8+ years experience in Pharma/Biotech
* Prior leadership in LIMS validation
* Experience leading validation of critical business systems and creating and executing validation deliverables (protocols, tests, IQ/OQ/PQ, etc).
* Proven experience with systems validation lifecycle (from URS development through system retirement)
* Proven experience in overseeing design, development and implementation of software; proficiency in SDLC
* Solid understanding of GMP Part 11
* Understanding of continuous process improvement (Six Sigma, Lean)

Terms
* Contract Position (6-9 months)
* $80+ hourly rate DOE

Apply now for immediate consideration. Qualified candidates will be contacted within the next 2 weeks with specific details.

To find out more about Real Staffing please visit www.realstaffing.com