Title:  Officer, Documentation - Production - Hikma I - Line 2

Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people in need. 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 an Officer, Documentation (m/f) to integrate Production - Hikma I - Line 2 Department, on-site work 

Main Responsibilities:

• Stays updated with internal quality standards, evolutions in GxP/GMP compliance and best practices.
• Reviews manufacturing documentation generated by Production Departments, including executed batch records, logbooks and forms ensuring completeness, accuracy, and GMP compliance
• Issues and attaches all required documentation to executed batch records, including machine production reports (when applicable), environmental and non-viable particle monitoring records, Yokogawa records, and other relevant supporting documentation
• Performs all required informatics system transactions in Sage X3, including production declarations, material transfers, returns, and rejected materials processing
• Verifies consistency between executed batch records and Sage X3 entries, identifying, reporting and resolving discrepancies 
• Acts as a SME for overall Production generated Documentation and gives training to individuals / teams for Documentation related subjects (i.e Quality Circles, re-trainings).
• Comply with GMP requirements, internal procedures, and data integrity principles
• Performs job tasks in strict adherence to Standard Operating Procedures (SOPs), Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) requirements. In addition, fills out all necessary department forms, logbooks and washing/depyrogenation/capping/filtration/environmental control/disinfection/laundry records

Profile:

• Degree in pharmaceutical manufacturing operations and/or documentation activites (Preferred)
• Pharmaceuticals Manufacturing Process (GMP's)
• Attention to detail
• ERP Systems (Sage X3)
• Computer Skills (Word, Excel)
• English (Basic to intermediate)

We offer:

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

If you would like to be considered for other positions, please complete the following form: https://forms.office.com/r/saCR9C3kCp

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