Title:  Sr. Officer, Documentation

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 1000 employees and 3 factories for the production of injectable medicines. 

Hikma, intends to recruit an Sr. Officer, Documentation (m/f) to integrate Production - Hikma IV department, on-site work 

Main Responsibilities:

• Stay updated with internal quality standards, evolutions in GxP/GMP compliance and best practices
• Coordinate the delivery and approval of the report investigations for production and verification and declaration of the executed batch records under the defined timeliness.
• 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 Line 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.
• Overlook production batch record reviewing process and insuring the delivery within required timeframe  

Profile:

• Degree in technical/science, engineering, or medical fields
• 3-5 years in Pharmaceutical Operations and/or Quality Department (preferable)
• 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 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