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Medochemie - Computerized System Validation Manager

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#ML07147
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 Computerized System Validation Manager for our offices in Limassol, CYPRUS.

Duties:

  • Provides oversight to assure that computerized systems are selected, implemented and maintained in compliance with applicable quality procedures, regulations and guidelines.
  • Promote compliance, quality and best practice-oriented culture regarding computerized systems.
  • Manage validation deliverables produced for computerized system projects, including operational procedures, maintenance procedures and change requests.
  • Support the development of Computerized Systems QA related procedures.
  • Conduct audits of computerized system vendors and 3rd party software providers.
  • Provide expertise and support during audits and inspections.
  • Proactively identify risks and issues. Drive implementation of pragmatic, compliant, quality based solutions.
  • Lead on-going initiatives and improvement projects in areas related to computerized systems and regulated data, as assigned.
  • Support the response and remediation of corrective actions.
  • Collaborate with key business partners including IT, Vendors, Quality SMEs and Business System Owners to ensure activities are performed in line with regulatory requirements and industry standards.
  • Responsible for all activities related to computerized system validation Follow cGMP related guidelines and GAMPv5 methodology.
  • Monitor the lifecycle of the validated software.
  • Secure data integrity.

Qualifications:

  • University degree in Computer Science or BIS or other relate field.
  • Minimum 5 years of work experience.
  • Experience with software testing, preparation and execution of UAT is a must.
  • Knowledge cof GMP Annex 11 or  GAMPv5 would be consider as an advantage
  • Excellent command of the English language, both written and verbal.
  • Excellent communication and interpersonal skills.
  • Ability to travel abroad

Job 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:

http://www.medochemie.com/

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.