QA Advisor / Senior QA Advisor
, Pennsylvania
January 25, 2017
Basic qualifications:
• Bachelors degree in Life Science or Engineering related discipline
• Three (3) or more years of working experiences in pharmaceutical or medical device industry
• Two (2) or more years of working experiences in validation or quality assurance with understanding of validation practices in one (1) or more of the following:
• Facility and Utility Validation
• Process Equipment Validation
• Analytical Equipment Validation
• Facility and Utility Validation
• Process Equipment Validation
• Analytical Equipment Validation
• Computerized System Validation
• Knowledge of pharmaceutical industry regulation (cGMPs and EU Regulations)
• Understanding of Quality Management Systems
• Oral and written communication skills
• Interpersonal skills and negotiating skills
• Organizational and planning skills
• Able to work on multiple projects and able to adapt to changing priorities

Preferred qualifications:
• B.S degree in Engineering
• Experience in conducting Quality Investigations
• Experience in conducting Equipment Vendor Assessment
• Experience in supervising or managing personnel
• Lean Sigma Certification (Blackbelt or Greenbelt)
• Understanding of risk-base approach for Validation

Set QA expectations related to the required validation documentation for capital projects
Key Responsibilities:
• Review and approve Validation Lifecycle documents including but not limited to
• Impact/Risk Assessment
• Specification Document (URS, FS, SDS etc.)
• Protocols (IQ, OQ, PQ, SAT)
• Report (VR, PVR)
• Change Control
• Make go no go decisions regarding the release of process equipment, facilities/utilities and/or analytical equipment for GxP usage
• Provides guidance and direction to manage and resolve complex product and/or system failure investigations
• Evaluates discrepancies in manufacturing and validation documentation
• Identifies risk associated with job responsibilities and suggest/implements risk mitigation plans
• Assist in the implementation of the PCQA Ops strategic plans to facilitate day to day operations and process improvements initiatives
• Support/manage routine assessments/audits
• Plan, organize and conduct Equipment Vendor Assessment


Contact information:

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