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Executive Director - QA/QC Rutgers, NJ

This position is responsible for the organizational and programmatic elements of Quality Assurance, Quality Control, Microbiology, Training & Documentation, CAPA / Investigation and Validation. Key responsibilities relate to sterile product manufacture, aseptic processing and control of environmental integrity, in accordance with applicable regulatory criteria and industry standards. This responsibility includes, but is not limited to, the effective planning and organization of personnel and workflow utilization (throughout the product life cycle) in order to implement the timely submission, approval, validation, testing and release of products and processes. This requires consistent successful application of internal quality system policies, procedures, and external regulations and standards that govern the products manufactured, labeled, tested, stored, promoted and/or distributed. In addition, the position ensures that short and long term plans are made and executed so that the current and future facilities and systems, manufacturing capacity and capability, and materials needs are met

Responsibilities

  • Cooperates with other top management personnel in formulating and establishing company policies, operating procedures, and goals
  • Insure compliance with the federal regulation and administrative policies of the laboratories
  • Develop and maintain quality systems
  • Coordinate and review facility calibration and validation programs
  • Conducts FDA inspection and furnishes the response of FDA 483
  • Review and approve investigations (OOSs, Non-Lab OOSs and deviations)
  • Review and provide appropriate information to regulatory for ANDA/NDA filings
  • Review of quality performance metrics/trends and analysis
  • Review vendors audit program
  • Annual record review
  • Maintain and coordinate the facility QA Documentation System (SOPs, Master Batch Records, and Specifications)
  • Investigate customer and product complaints
  • Review and approve validation protocols.
  • Carries out responsibilities in accordance with the organization's policies and applicable laws.
  • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems;
  • Assist and Manage Quality Assurance, Quality Control, Microbiology, and Validation departments with work related projects.

Qualifications

  • Bachelor's degree (BS) in the Life Sciences (e.g.,Chemistry, Microbiology, Biology, Biochemistry) or Pharmacy from an accredited four-year college or university
  • A minimum of five to ten years of experience related to the pharmaceutical manufacture, specializing in sterile dosage forms.

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