MIR Scientist, 1st Shift

4 weeks ago


Cherry Hill, United States Hikma Pharmaceuticals Full time

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.

Location:

Cherry Hill, NJ, US, 08003

Nearest Major Market: Philadelphia


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