Title:  Officer, Documentation - H1

Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people who are competent. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.

At the end of the 1980s, we extended ours beyond the Middle East and acquired land in Portugal for the construction of a sterile factory for injectable pharmaceutical products. This was an important turning point for the company, and our first step into a new region. Today, in Portugal, we have more than 900 employees and 3 factories for the production of injectable medicines. 

Hikma, intends to recruit a Officer, Documentation (m/f) to integrate Compounding - Hikma I/B Department, on-site work 

Main Responsibilities:

• Stays updated with internal quality standards, evolutions in GxP/GMP compliance and best practices.
• Performs/evaluates/writes root-cause investigation and impact analysis for production reports (critical, major, minor, and environmental monitoring deviations) according to current standards and procedures.

• Working together with Operators/Production Lines Supervisors/Manager defines CAPAs based on root cause analyses and trending of reoccurring Production Investigation Reports.

• Writes Production reports (Investigations, MEMO’s, Protocol Reports) and SOPs

• Revise MBR (master batch records) for production (filling and compounding) for commercial products, new launches for EU/Canada markets.

• Opens and manage change controls for production for line transferences and process improvements.

• Acts as a SME for Production investigation reports and gives training to individuals (i.e, Quality Circles, re-trainings) as well as classrooms (annual cGMP training program)

Profile:

• Degree in Technical Science (Chemistry, Pharmaceutical, Microbiology), Engineering or Medical fields
• Experience in Pharmaceutical Operations and/or Quality Department
• Proactive and Organized
• Pharmaceuticals Manufacturing Process (GMP’s)
• Pharma Quality Standards & Systems Management
• GXP Quality Assurance
• Familiar with root cause analysis techniques and product impact tools (e.g. FMEA)
• Computer Skills (Word, Excel, Power Point)
• Fluency in English, written & spoken

We offer:

• Direct contract with Hikma
• Salary appropriate to the functions performed
• Life insurance
• Health insurance
• Annual Performance Bonus
• High career prospects

If you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every day