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MIR Scientist, 1st Shift at Hikma Pharmaceuticals
Cherry Hill, United States


Job Descrption

Responsible for managing the day-to-day manufacturing deviations (MIRs) Investigations within a section or functional area. Identify and assess quality risks in activities and processes related to manufacturing and follow West-Ward quality and current good manufacturing practices(c GMP). Participate and drive departmental Investigations to closure. Assist/drive and /or lead, Change Controls (CCRs), Customer Complaints and Annual Product Review (APRs).

 

  • Ensure timely closure of in process and finished product investigations (MIRs).
  • Write and Review Annual Product Reviews.
  • Perform / Assist in Customer Complaints by collecting and analyzing objective evidence regardingrisks and corrective actions to remediate.
  • Maintain a high level of Expertise in West-Ward’s Quality Systems and Current Good Manufacturing Practices in resolving technical issues.
  • Participate in manufacturing projects in the role of contributor, coordinator or leader.
  • Bachelor degree in the sciences or engineering. Strong Chemistry and/or Microbiology background preferred.
  • 3-5 years experience in pharmaceutical processes or manufacturing.
  • Exceptional organizational skills and ability to plan and implement resolutions to technical problems.
  • Familiarity with current good manufacturing practices and quality systems related to asepticprocessing.
  • Understand scientific strategies and be able to explore all avenues of investigation.
  • Good interpersonal/ communication skills.
  • Good project management skills.
  • Working knowledge of FDA regulations with regards to Annual Product Review.

 


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HIKMA PHARMACEUTICALS
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