Title:  MIR Scientist

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 Hikma quality and current good manufacturing practices (cGMP). 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 regarding risks and corrective actions to remediate.
• Maintain a high level of Expertise in Hikma’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 aseptic processing.
• 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.