Quailty Systems Manager

RESPONSIBILITIES:
* Actively support, enforce, and comply with current Good Manufacturing Practices, Business Conduct Guidelines, Corporate and Plant Policies/Procedures, Standard Operating Procedures (SOPs), and Safety Policies.
* Ensure that colleagues have the necessary skills to perform their job functions including specific job knowledge and understanding of applicable regulations (e.g. cGMPs; DEA, etc.) and that SOPs are understood and consistently followed
* Directs supervision of Quality Engineering encompassing management and administration of: Process validation; software validation; calibration program and establishment of equipment maintenance program in conjunction with departments within the facility
* Directs supervision of Documentation/Change Control to include tracking of review/disposition of change requests, tracking implementation of change requests, ongoing review and enhancement of facility documentation systems to include verification of adequacy of procedures through comparison to actual practices
* Provides oversight and management of Master Validation Plan to assure that all facility equipment and processes are operated within validated parameters; and Master Cleaning Validation Program to ensure the ongoing adequacy of all cleaning validation programs for new and existing products
* Implements and maintains all Laboratory Computer Data Systems and trains departmental personnel on use of Laboratory Data Systems
* Functions as the Manager of Laboratory Systems in the absence of the designated Manager
* Functions as the liaison with Corporate IT for Laboratory Data Systems
* Provides for the ongoing development of subordinates through skills enhancements, mentoring and training so as to optimize their contribution
* Promotes and maintains a positive work environment by behaving and communicating in a manner consistent with professional standards in dealings with all colleagues, management, and visitors
* Performs a variety of special projects or tasks as required to meet Department and Company objectives

REQUIREMENTS:
* Bachelor of Science (BS) in a Scientific discipline
* Min. 8 years in Pharmaceutical Manufacturing Environment
* Min. 5 years Supervisory Experience
* Min. 5 years in Computer/Process Validation

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