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Validation Manager

Department: Validation
Location: West Columbia, SC

VALIDATION MANAGER

Position Summary:

  • Oversee and manage validation activities
  • Assists with additional work duties or responsibilities as evident or required.
  • Performs other duties as assigned or apparent.

Primary Accountabilities:

    • Responsible for leading and coordinating the work required to validate manufacturing process.  This role will interact as a core team member with Manufacturing, Quality Control, R&D Engineering and Quality Assurance staffs to ensure that manufacturing process validation performed are appropriate and comply with applicable regulatory and company validation requirements.
    • Lead and coordinate process validation related activities according to established plan to ensure that manufacturing processed products are validated in accordance with cGMP’s, corporate policies and procedures.
    • Provide validation approach and feedback on process validation projects, criticality assessment and review of changes
    • Review manufacturing process validation data to ensure completeness and accuracy
    • Create and review study design, development and evaluation of acceptance criteria, and data analysis
    • Supervise staff, monitor processes to identify opportunities for continuous improvement related to the Process Validation activities. Initial, final review and approve installation, operational and performance qualification protocols for production equipment, laboratories (Micro & Chemist) and production processes. Verify that validation protocol instructions are followed and validation has been timely completed to make sure company is in compliance. Review summary reports and statistical analysis for the completed qualifications.  
    • Manage work with proper distribution of responsibilities and projects within validation specialists for execution of validation protocols.
    • Manage calibration activities. Review approved in-house and outside calibration raw data and certificates. Perform trend analysis overtime. 
    • Provide necessary training to all personnel and maintain their training records.



Knowledge, Skills & Abilities:
NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

  • Bachelor’s Degree in Science (4yrs) from regionally accredited university and/or 5 years’ experience in Pharmaceutical or Engineering Industries.
  • Work experience in clean room. Excellent cGMP and FDA regulations knowledge.
  • Strong leadership, Organizational and Management skills.
  • Experience with Validation activities. FDA guidelines and GMP training.
  • Specific expertise, skills and knowledge within quality assurance gained through education and experience.
  • The ability to utilize knowledge of the competition to determine business strategies and decisions.
  • A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities.
  • The ability to take strategic objectives and accept accountability to drive results through effective actions.
  • The ability and willingness to change direction and focus to meet shifting organizational and business demands.
  • The ability to set clear targets and use performance measures to   assess risk and opportunities in order to effectively manage the assets of the business.
  • The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
  • The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
  • The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity.
  • The ability to manage a multitude of resources and to be accurate and current with data and information.
  • The ability to create new products and processes that add value to the Business, by generating new ideas and applying creative and analytical approaches.
  • Position requires bending, typing, climbing, lifting, reaching, vision (20/20), standing, sitting (60%), walking, and hearing.
  • Salary range: Based on experience

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