Officer, Documentation - Planning & Support Office
Hikma Pharmaceuticals
Remoto
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
- 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)
- 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