Key Responsibilities:

• Ensuring the establishment and dissemination of data integrity culture within the production facility
• Making organization with relevant departments in the production facility to ensure compliance with data integrity principles (ALCOA+: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available) of structures that generate electronic or manual data such as systems, equipment, processes, and documentation
• Planning, implementing and reporting the required technological improvement activities by defining user access, data backup and audit trail review criteria
• Planning, implementing and reporting gap analysis and risk analysis studies
• Determining the actions to be taken with the relevant departments in order to eliminate the deficiencies in compliance with the regulations and to follow them
• Fulfilling the requirements within the scope of data integrity procedures and to follow up the applications
• To keep the relevant procedures up to date by following the regulations regarding data integrity
• Represents the company as a subject matter expert during regulatory and customer audits for data integrity
• Ensuring that data integrity perspective and updated information on the subject are provided to employees through recruitment and periodic trainings
• To present studies and requests on data integrity to senior management
• All works shall be carried out in accordance with the company’s quality policy, goals and obligations arising from current GMP, ISO 9001; ISO 27001; ISO 13485 standards

Additional requirements:

• To follow developments in cGMP, cGDP and Quality Assurance System
• To follow the technological developments in the professional zone
• Graduate of a University/associate degree
• Proficient in using MS Office programs.
• Minimum of 5 years’ experience in data integrity compliance role
• Attentive to Occupational Health and Safety regulations.
• Team player.
• Able to work under intense workload when necessary.

Interested candidates can send their CV by indicating the position name in subject to the e-mail address in the Apply for job button.