Title: Analyst, Quality Systems & Validation
Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people who are competent. 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 Analyst, Quality Systems & Validation (m/f) to integrate Injectables - Quality Systems Department, on-site work
Main Responsibilities:
- Ensure layouts meet GMP and internal standards.
- Create and update layouts for Hikma Portugal and other sites as needed.
- Prepare a monthly dashboard for the layouts program.
- Support the team with the validation activities for new projects across sites.
- Ensure department SOPs and documentation are controlled.
- Harmonize procedures within the Injectables division.
- Support audit preparation and execution. Assist in preparing audit reports and responses.
- Perform follow-up actions based on audit observations.
- Monitor the training plan and act as Training Coordinator in the database.
- Manage purchase orders: request quotes, issue PDCs, ensure documentation, and update budget control
Profile:
- Degree in Engineering (Mechanical, Electromechanical, Material, Civil)
- Technical drawing software/tools
- GMP Knowledge (EU and US Guidelines)
- Knowledge of the manufacturing process and internal procedures of Hikma Pharmaceuticals, Injectables
- Proficiency in CAD software and Microsoft Office
- Strong organizational and communication skills
- Ability to work under pressure and manage multiple tasks
- Diligent, assertive, pro-active, self-motivated, detail oriented
We offer:
- 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
Sintra, Sintra, PT