Position

Manager, QA Validation (Lynchburg, VA)


Department:

Quality Assurance

 

Manage the functions for validation of product and cleaning of in-house manufacturing and packaging systems. This includes commissioning, engineering studies, IQ/OQ/PQ, process validation and cleaning validation. Serve as management representing Validation during internal and external audits.  Lead technical evaluation on process investigation and validation troubleshooting.  Develop company validation standards that meet current industry standards for pharmaceuticals & train the key stakeholders.

Image removed.Major Job Accountabilities and Responsibilities

 

Accountabilities

  • Manage all company validation functions related to manufacturing, raw materials, packaging, testing, and distribution of our products, including writing protocols and final reports, reviewing testing methods, and analysis of data.
  • Lead validation staff and resources provide training and coaching.
  • Provide oversight, writing and execution of commissioning documents and Engineering studies and IQ/OQ/PQ, process validation and cleaning validation.
  • Development and execution of a validation program that complies with industry standards and applicable government regulations.
  • Provide technical assessment and support for validation and investigations and effectively develop & write risk assessments.
  • Moderate direct impact on profitability results from maintaining proper adherence to validation and stability guidelines.

Responsibilities

  • Manage the development and writing of validation policies, procedures and protocols in validation program.
  • Manage the IQ/OQ/PQ, cleaning and utilities validation. Work closely with Engineering on new equipment specifications and engineering changes as related to process and cleaning validation.
  • Evaluate, identify and develop current company validation standards to meet global requirements and current industry standards.
  • Manage, coordinate and provide QA oversight for assembling and issuing New Product Technical releases prior to initial release of product to the market.
  • Manage, coordinate and provide QA oversight for line/ship tests and the calibration.
  • Participate in training and instruction of departmental personnel and provide technical leadership to the department.
  • Provide technical support and assessment for processes, validation activities and investigations.
  • Provide DOE (design of experiments) as needed for process, engineering studies and investigations.
  • Perform other related duties as required.
  • Perform FATs as needed and provide technical expertise for acceptance test on site.

Health, Safety & Environmental

  • Ensures regulatory and corporate compliance.
  • Leads by example.

Operational Performance

  • Ensures department goals are aligned with business imperatives.
  • Ensures performance goals are met.
  • Establishes and ensures achievement of all unit Key Performance Indicators (KPIs).
  • Ensures compliance with corporate standards (e.g., financial, code of business conduct) and adherence to company policies.
  • Supports business processes and requirements.

KPI Accountabilities/Responsible to Influence

  • Effective execution and sustanaibility of validated states
  • Achievement of Project schedules (%) and budgets (%)
  • Planned budget/actual budget (%)

People Management/Development

  • Promotes open and honest communication.
  • Fosters “team building.” 
  • Fosters a culture focused on problem solving and process improvement.
  • Ensures decision making at proper levels.
  • Ensures clear roles and responsibilities.
  • Engages workforce.
  • Maintains positive employee morale.
  • Aides in determining resource planning and deployment strategy.
  • Ensures systems and processes are in place to maintain smooth operations during employee absences and staffing changes.
  • Fosters culture that values diversity and promotes respect, inclusion, cooperation and responsibility.

Image removed.Qualifications

Minimum Education and Experience Requirements

 

Requires the knowledge gained through a BS degree in Math, Science, Engineering or related field with a minimum of 7 years technical experience in pharmaceuticals industry with a proven track record. Five years supervisory experience necessary in Validation and/or Technical Services. In-depth knowledge of current industry validation practices is required.

Skills, Knowledge and Abilities

 

 

  • Requires a thorough knowledge and a strong record of accomplishments in technical areas and quality processes areas. DOE experience preferred.
  • Excellent communication skills and strong leadership skills are required.
  • Extensive verbal and written skills and word processing and statistical software are required.
  • Extensive knowledge of cGMPs required.

Prestige is an Equal Opportunity Employer

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