Job Details

  • Title: Sr. CAPA or Deviation Specialist
  • Code: RCI-9635
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 07/31/2020
  • Duration: 6 Months
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  Job Description

Client is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

PURPOSE AND SCOPE OF POSITION

This position is responsible for the Quality CAPA Process and System ownership. In this role, the incumbent will serve as business process owner for the CAPA module and the associated governing local procedures and supporting processes. This is a highly visible role with site responsibility and cross-functional influence that has impact on departmental performance and broad quality CAPA management. The incumbent will be the primary CAPA process subject matter expert across the site.

DUTIES AND RESPONSIBILITIES

  • Manages the CAPA Quality System for all GMP activities and works with responsible cross functional areas ensure timely completion
  • Ensure appropriate corrective or preventive actions are generated to increase compliance and prevent repeat occurrences of CAPA’s
  • Provides end-user training on CAPA process and system
  • Compiles applicable process metrics, identifies trends and escalates accordingly
  • SME support during internal and health authority inspections of facility
  • Communicates effectively with cross functional stakeholders on matters related to CAPA process
  • Performs, supports and trains others on how to perform Root Cause Analysis by using problem solving methods used to identify cause for non-conformances and quality problems
  • Supports Quality Systems harmonization efforts
  • Performs other tasks as assigned
EDUCATION AND EXPERIENCE:
  • College or university degree preferred
  • Experience in the pharmaceutical or related industry
  • An equivalent combination of education and experience may substitute
  • 10-15yrs GMP experience - hands on investigation and root cause analysis skills
  • Been in audits and can lead / drive and influence
  • Strong communication skills and the ability to work under pressure
  • Must have experience with cGMP manufacturing, Quality, and Compliance
  • Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles
  • Must be able to routinely recognize quality issues and interpret problems, as well as propose solutions for complex issues
  • Must understand continuous improvement and be able improve the compliance and efficiency of the quality system
  • Must be able to effectively prepare and convey data analysis to management and others within the group with clarity and accuracy
  • Must be self-directed, complete routine tasks independently and be confident in making decisions in respective subject matter area, consulting with management for decisions outside of established processes
  • Requires moderate direction to complete more complex tasks
  • Comfortable providing input/guidance to others within the department and across the organization in CAPA technical writing
  • Strong knowledge of problem-solving methods used to perform Root Cause Analysis
  • Propose solutions for issues and work with management to resolve
  • Comfortable providing training/guidance to system users as needed, and in instructor-led settings
  • Able to recognize conflict and notify management with proposed recommendations for resolution
  • Able to prepare written communications and communicate problems to management with clarity and accuracy
  • Able to support internal and health authority inspections of facility