Lupin Pharmaceuticals (Company Headquarters)

Pharmaceutical Manufacturing Investigations Specialist

1 month ago(12/21/2017 5:03 PM)
ID
2017-2230
# of Openings
1
Category
Quality Assurance

Overview

The Pharmaceutical Manufacturing Investigations Specialist reports to the Manager of QA Investigations and is responsible for activities related to the investigations/deviations/CAPA process. Responsibilities include conducting the investigations, writing summary reports, suggesting and implementing appropriate corrective actions, and verifying effectiveness of CAPA. Additional responsibilities include administrative and compliance support to the Quality department within the Lupin Somerset facility. To be successful in this position a person must have a thorough understanding of the pharmaceutical manufacturing process including but not limited to Blending, Granulation, Encapsulation, and Compression. Above average writing and communication skills are imperative.

Responsibilities

  • Write, and at times review, deviations related to manufacturing, packaging, warehouse, facility and engineering, etc.
  • Gather quantitative and qualitative data from various areas of operation for analysis (i.e., manufacturing floor, warehouse, etc.)
  • Provide review of investigation reports and supportive documentation (including data) for accuracy and completeness, where needed.
  • Aid and/or Conduct Root Cause Analysis (RCA) to evaluate each of the possible causes in order to determine the true root cause.
  • Propose, review and/or implement appropriate corrective actions and preventive actions (CAPA) based on the investigations
  • Perform Risk Analysis on the product disposition and involve MRB (Material Review Board) where necessary.
  • Verify the CAPA effectiveness periodically and modify the CAPA accordingly.
  • Organize and maintain files, maintain document templates; track document activities/status.
  • Develop and track meaningful investigations/CAPA metrics for management review and conduct periodic reporting on metrics and trends.
  • Assist management in filing FAR (Field Alert Report) to FDA and during FDA audits with respect to investigations and CAPA.
  • Assist in the development of policies, procedures and protocols for investigation-related practices.
  • Review current SOP’s, policies and systems with respect to quality documentation, modify and improve as necessary.
  • Attend training courses as necessary.
  • Perform other activities as required by the Compliance department

Qualifications

  • Bachelor’s degree in an engineering, scientific, or statistical field.
  • Expert knowledge of manufacturing processes and operations
  • 5+ years’ experience in pharmaceutical manufacturing with experince writing and editing SOP's
  • Working knowledge of root cause analysis tools a plus
  • Excellent technical writing skills
  • Working knowledge of QAMS
  • Prior experience with FDA audits is a plus
  • Working knowledge of Microsoft Word, Excel and PowerPoint is necessary

 

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 20 pounds occasionally. Generally work is performed in an office and or manufacturing environment.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed