Title: Officer, Documentation - Production - Hikma I/B 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 anOfficer, Documentation(m/f) to integrateProduction - Hikma I/BDepartment,on-site work.Main Responsibilities:Stays updated with internal quality standards, evolutions in GxP/GMP compliance and best practicesPerforms/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 ReportsWrites Production reports (Investigations, MEMO's, Protocol Reports) and SOPsActs 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, engineering, or medical fields3-5 years in Pharmaceutical Operations and/or Quality Department (preferable)Proactive and OrganizedPharmaceuticals Manufacturing Process (GMP's)Pharma Quality Standards & Systems ManagementGXP Quality AssuranceFamiliar with root cause analysis techniques and product impact tools (e.g. FMEA)Computer Skills (Word, Excel, Power Point)Fluency in English, written & spokenWe offer:Direct contract with HikmaSalary appropriate to the functions performedLife insuranceHealth insuranceAnnual Performance BonusHigh career prospectsIf you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every day.#J-18808-Ljbffr