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Quality Associate I, Quality Systems, Sintra
Client:
Hikma Pharmaceuticals
Location:
Sintra, Portugal
Job Category:
Other
EU work permit required:
Yes
Job Reference:
d63f68313341
Job Views:
2
Posted:
16.04.2025
Expiry Date:
31.05.2025
Job Description:
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 900 employees and 3 factories for the production of injectable medicines.
Hikma intends to recruit an Quality Associate I, Quality Systems (m/f) to integrate Quality Systems Department, on-site work.
Main Responsibilities:
- Issuance of investigation and trend reports for Quality complaints (complaints from customers and to suppliers)
- Issuance of risk assessments as per Quality Management Risk Approach in place
- Monitoring of KPI's/preparation of reports to Corporate and Quality Councils
- Change Controls – introduction of the information in the database, follow-up on the pending actions and archive of all Change Controls that are closed on SAGE/X3 system. Oversee of all change controls that are opened on Veeva QMS system; Issuance of Red-tags, Stop Notices and Risk Assessments for batch release
- Act as DocController in Veeva DMS – oversees document finalization system by reviewing metadata fields; maintains the database organized and oversees the documentation to assure its conclusion and approval/effectiveness. Follow-up on bi-annual revision of SOPs and layouts and issuance of controlled copies
- Approval of infrastructures / maintenance forms
- Management of the program for the Reserve Samples inspection/incineration and issuance of the calendar for the inspections on an annual basis
- Issuance of general (per line) and product-specific manufacturing process yields for the products manufactured at Hikma Farmacêutica (Portugal), S.A.
- Individual training on updated procedures, as per the approved training plan
Profile:
- Bachelor's degree or equivalent in Science
- At least 6 months of professional experience or training in Quality is essential
- Good knowledge of English
- Good knowledge of the applicable guidelines
- Strong sense of responsibility
- Ability to multi-task and to be highly organized
- Demonstrated ability in time management and flexibility in establishing priorities
- Computer skills, including experience in managing databases is preferred
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.
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