Job Description

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.

Hikma Pharmaceuticals