WuXi AppTec

  • Manager Validation

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4132
  • Overview

    Plan, implement and coordinate equipment and facilities validation responsibilities to insure site-wide adherence to cGMPs, compendial and customer requirements for the WuXi AppTec Philadelphia operations.

    Responsibilities

    • Coordinate all equipment and facilities validation activities as related to plant operations.
    • Review and approve all protocols, reports and studies as prepared and conducted for equipment and facilities validation.
    • Perform validation assessments for all equipment and facilities related change controls.
    • Review, revise and develop Standard Operating Procedures (SOPs) applicable to equipment and facilities validation and assist in the review and development of plant-wide SOPs.
    • Oversee, review and approval of the site Validation Mater Plan and Validation Project Plans.
    • Support the generation of risk assessments for various equipment and facilities related validation activities.
    • Represent validation during agency and client audits (as needed) on matters pertaining to equipment and facilities validation responsibilities.
    • Coordinate and track the corrective/preventive action follow-ups to client audits for equipment and facilities related validation issues and activities.
    • Manage resource loading and manpower requirements associated with equipment and facilities validation activities or in support of internal / external client projects. This includes managing external validation resources.
    • Assist with the preparation of equipment and facilities validation budget for capital projects.
    • Prepare request for proposals for external equipment and facilities validation resources. Review bids and prepare bid award recommendations for upper management approval.
    • Determine and coordinate the training needs of employees directly involved in the functions associated with Equipment and Facilities Validation.
    • Assist with the development and tracking of the department budget.
    • Periodically update the Site VP/General Manager of relevant validation activities
    • Support other site departments with periodic reviews and collaboration on computer system validation, aseptic media simulation programs, and environmental monitoring programs.
    • Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
    • Plans, monitors, and appraises direct reports including performance competencies, goals & job results
    • Coaches, counsels, and conducts disciplinary actions
    • Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
    • Contributes to the overall operations and to the achievement of departmental goals
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
    • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
    • Other duties as assigned
    • May be required to assist in other departments

    Qualifications

    Experience / Education:

    • HS Diploma or equivalent required and
    • A minimum of 10 years of relevant experience in the pharmaceutical industry in a validation or quality related position and min. 2 years managing others
    • BS/BA in a Natural Science, Engineering or other related field

    Knowledge / Skills / Abilities:

    • Proficient in Oral & Written communication skills
    • Needs to be able to read, write and understand English
    • Working proficiency Microsoft Office (Word, Excel, and Projects).
    • Master Control, Trackwise or related quality control software experience
    • A minimum of 10 years of relevant experience in the pharmaceutical industry in a validation or quality related position

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled 

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