HEAD OF PROCESS VALIDATION - LIMASSOL

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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 Head of Process Validation for our offices in Limassol, CYPRUS.

Duties:

·         To coordinate preparation of process validation protocols, final reports for and Holding Times Studies for all the Company’s facilities.

·         To coordinate execution of  process validation protocols according to the Master Plan

·         To review protocols and reports prepared by other members of the Team.

·         To ensure that the Process Validation protocols have been executed and completed as per requirements and all the deviations have been recorded accordingly.

·         To write Standard Operating Procedures for the Process Validation Department.

·         To provide information to other Departments of the Company when needed.

·         To write and follow up Validation Master Plan for Process Validation.

·         To prepare transfer protocols and reports for trials and scale ups of new products and charts with suggested limits of IPC tests.

·         To assist with Risk Management projects.

Qualifications:

·         University degree in Pharmacy, Chemical Engineering or other relevant discipline. A post graduate degree will be considered an asset.

·         At least 5 years of experience in Process Validation in a Quality Assurance Organization.

·         At least 10 years of experience in cGMP Environment.

·         Understanding of cGMP requirements and other FDA/EU regulatory requirements associated with manufacture of pharmaceutical products and associated equipment and facilities is essential.

·         Knowledge of statistics and their application to such aspects as process sampling and data trends analysis.

·         Practical experience with quality risk management and risk based validation approaches.

·         Excellent command of the English language, both written and oral.

·         Significant knowledge of and experience with FDA/cGMP regulations is required.

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/MainMenu/Careers.aspx