Validation Specialist (Production Equipment) İş İlanı

İşveren Hakkında

QUALIFICATIONS AND JOB DESCRIPTION

Qualifications

  • Bachelor’s degree in chemical engineering,
  • Minimum 2 years of experience in qualification/validation,
  • Familiar with qualification/validation activities
  • Able to use MS Office programs effectively,
  • Upper intermediate level in English both written and spoken,
  • Responsible, team oriented, result-focused, good communication skills

Job Description

  • Coordinates and conducts qualification/validation activities of Production/Lab Equipment and Critical Auxiliary Systems which are supposed to be executed according to national and international rules by managing sources the most effective and efficient way,
  • Coordinates and organizes qualification/validation activities of Production Equipment and Critical Auxiliary Systems,
  • Prepares plans and protocols which are related to qualification/validation activities,
  • Prepares validation reports by evaluating results which are obtained from executions,
  • Determines and follows up necessities for qualification/validation activities,
  • Determines the state of qualification/validation studies required in the Quality Assurance System and makes suggestions in order to use these qualification/validation requirements in the preparation of annual plans and validation master plan,
  • Ensures the preparation of annual plans for the activities of Equipment and Critical Auxiliary Systems,
  • Ensures the follow up of the monthly realizations for the qualification/validation under own responsibility and determines actions to avoid any failures of realizations,
  • Ensures the preparation of Annual Validation Master Plan with the relevant departments,
  • Performs the required controls in order to provide the execution of the qualification/validation activities within the direction of the plans,
  • Plans and follows up the actions for new equipment and systems with the related departments,
  • Does or makes it done the required studies in order to complete qualification/validation activities in the plan properly,
  • Determines equipment / systems / devices to be verified with the relevant departments,
  • Delivers own opinion upon determining the requirements of the qualification/validation,
  • Follows up of qualification/validation activities,
  • Prepares standard operating procedures,
  • Represents qualification/validation activities to the auditors.