GMP Compliance and Validation Specialist

Humanis

Humanis, established in 2010 with the understanding of "How Happy is the One Who Offers a Cure" is one of the largest generic pharmaceutical companies in our country and continues to bring hope to the patients in Turkey and throughout the world.

 We believe that our team is the most valued resource for our success and we can build a better future together.

 We are looking for a "GMP Compliance and Validation Specialist" to be assigned to the GMP Compliance and Validation Department of our factory in Çerkezköy.

• Graduated from Chemistry, Chemical Engineering or Pharmacy departments of universities.
• Preferably with at least 3 years of experience in similar positions in the pharmaceutical industry,
• Able to use Microsoft Office at advance level,
• Advanced knowledge of English,
• Able to adapt to intensive work,
• Inclined to team work, strong communication, analytical thinking features,
• For male candidates military service duty’s should be completed,
• Residing or able to live in the vicinity of Çerkezköy, Kapaklı, Saray, Çorlu, Ergene, Lüleburgaz, Avcılar, Beylikdüzü, Büyükçekmece.

JOB DESCRIPTION

• To establish systems that assure quality together with all relevant departments within the organization and to be responsible for auditing,
• To prepare and maintain the procedures related to the quality assurance system specified in the general file of the facility and to take the necessary actions to solve the problems that may arise,
• Taking part in customer and authority audit studies,
• Preparation and updating of annual validation master plans,
• Organizing validation studies with other departments and to follow their timing,
• Preparation of validation protocols,
• Collection, evaluation and reporting of the results of the validation studies,
• Determining the actions to be taken after doing risk analysis when necessary.