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Description:
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 Planning & Support Office Department, on-site work reporting to the Manager, Planning & Support Office - Cláudia Costa
Main Responsibilities:
Stays updated with internal quality standards, GMP compliance and best practices.
Generates/Revises master batch records and bill of materials for Inspection, labelling and packaging activities for commercial products, new launches and submissions, in agreement with the relevant change controls
Generates/revises procedures (APAIs, VPAIs, Wis) in agreement with the relevant reports, risk assessments and Memo’s related to manufacturing activities
Performs/evaluates root-cause investigations and impact analysis for Manufacturing operations in Hikma 3 building and writes them in agreement with current standards and procedures.
Works together with Operations’ Supervisors/Managers to propose/define CAPAs based on root cause analysis and trending of recurring investigations
Issues Memo’s for Manufacturing operations in Hikma 3 Building
Gives support to planning activities when needed
Issues a monthly report to record the activities performed and KPI status. Also an analysis regarding the investigations for manufacturing operations in Hikma 3 building and implemented CAPAs
Profile:
Bachelor’s degree or equivalent in technical/science, engineering, or medical fields
3-5 years in Pharmaceutical Operations and/or Quality Department (preferable)
Proactive and Organized
Ability to work in a highly structured environment and work independently and as part of a team
Fluency in English, written & spoken
Computer Skills (Word, Excel, Power Point)
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)
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
Location:
Sintra, Sintra, PT
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