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MIR Scientist 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.
What We Offer
- Clean climate-controlled working environment
- Annual performance bonus potential
- 401k employer match up to 6% of your contributions
- 23 vacation/personal days
- 11 paid Company holidays
- Generous healthcare benefits
- Employee discount program
- Wellbeing rewards programs
- Safety and Quality is a top organizational priority.
- Career advancement/growth opportunities
- Tuition Reimbursement
- Maternity and Parental Leave
*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program term
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