Quality Assurance Associate/ Specialist (Systems Validation)
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#ML21434 Type: Full time
Medochemie Ltd is an International Pharmaceutical Company headquartered in Cyprus. Medochemie manufactures a wide range of products divided into more than 10 therapeutic categories, owns 4355 marketing authorizations and operates in more than 107 countries around the world. Our thirteen separate manufacturing sites are designed to fully comply with European and WHO current Good Manufacturing Practice (cGMP).
Medochemie Ltd invites applications from career-oriented professionals for the position of Quality Assurance Associate or Specialist in our offices in Limassol, CYPRUS.
- Responsible for the quality aspects of computerized systems used in site facilities to ensure compliance with company policies, procedures and regulatory expectations
- Assure all systems, processes and their outcomes comply with quality standards
- Keeps informed of all existing and new regulatory requirements and helps maintain compliance in the company’s quality systems
- Evaluate proposed and existing systems, prioritize risks and address data integrity gaps
- Review processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective
- Review software change requests and test scripts
- Develop validation reports
- Supporting regulatory inspection and audit activities as needed and taking appropriate actions to ensure GMP compliance related to computerized/automated systems
- Bachelor's degree in a science discipline
- Strong computer literacy skills and knowledge of backups. Working knowledge of computer validation or system testing development and execution will be considered as advantage
- Related experience in a pharmaceutical industry is a plus
- Proficiency with MS office tools (Word, Excel, Vision, PowerPoint, Project Plan, etc),
- Excellent command of the English language, both written and oral
- Advanced project management and technical writing skills is preferred.
- Ability to work in a team environment and prioritize work in a dynamic and fast moving environment.
Location: Limassol, CYPRUS
We are offering an attractive remuneration package and challenging opportunity for professional development.
If you wish to work in a pleasant, modern, professional environment with excellent career opportunities, please apply online through our web site.
Applicants should note that based on the General Data Protection Regulation (GDPR), all applications/CV’s kept in our database have been deleted. In case you have forwarded us your CV in the past and you are interested in this position, please apply again.
All applications will be treated in strict confidence.