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Title:  Quality Computerized Systems Specialist (m/f)

Description: 

Founded over 40 years ago by Samih Darwazah in Jordan, Hikma's purpose is to provide high quality, affordable medicines to people in need. Building on very strong foundations, we continue to innovate and find practical solutions every day to transform the lives of the millions of people we serve.
In the late 1980s we extended our reach beyond the Middle East and acquired land in Portugal to build a sterile manufacturing plant for injectable pharmaceuticals. 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 production plants for injectable pharmaceuticals.
Hikma, intends to recruit a Quality Computerized Systems Specialist (m/f) to integrate our Quality department.

 

We value the sense of responsibility, taste for challenges, proactivity, motivation and team work as well as autonomy, empathy and transparency.

 

Job description/Main Responsibilities:

Implementation of policies and procedures to validate/qualify computer systems.
Liaises with IT and other cross-functional business teams in the development of GxP deliverables, SOPs, Work Instructions, Policies and other critical documentation for GxP regulated computerized systems
Ensure GxP computer systems are designed, validated and operated in compliance with applicable regulatory requirements and Hikma’s internal procedures.
Responsible for assuring full adherence to procedures, by IT department, regarding access controls, backups and audit trails of GxP systems, by performing periodic reviews to the systems;
Responsible for reviewing and approving validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, testing Protocols, Reports, Traceability Matrix, and Standard Operating Procedures.
Assure maintenance of accurate validation documentation;
Participate in data integrity risk assessments and / or Design FMEAs;
Lead process improvement projects to improve the validation of computerized systems.
Compliance to all local site company policies, procedures and corporate policies;
Communicate Computer System Validation approaches and requirements during audits;
Perform additional duties at the request of the direct supervisor.


Qualification/Experience:

High degree on engineering (sciences preferable)
Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Annex 11, GAMP5

 

We offer:

Salary package appropriate to the duties performed
Health insurance
Life insurance
High career prospects


If you think this is a good opportunity for your professional career, join us and contribute to better health, within reach, every day.

Location: 

Sintra, Sintra, PT

Apply now »