Quality Assurance Specialist/ Assistant Specialist İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
Mefar Pharmaceuticals, is the highest-capacity production and development service provider (CDMO) in Turkey and the neighboring region for sterile injectable products. We are looking for a"Quality Assurance Specialist / Assistant Specialist” for our Quality Directorate.
Qualifications
- Bachelor’s degree in Chemistry or Chemical Engineering preferably having recently graduation,
- Fluency in English,
- Positive, solution oriented, team player, good communication skills,
- High sense of responsibility and ability to work with critical timelines,
- Multitasking ability in a dynamic environment,
- Advanced organization skills and follow up skills, result oriented.
Job Description
- Planning of re-qualification of sterilization and depyrogenization equipment preparation, application and reporting of protocols,
- Organizing field qualification and field re-qualification practices in the scope of clean room validation and preparing related reports,
- Supporting the creation of the necessary in department documentation (protocols, reports, procedures, instructions etc.) in order to carry out equipment and system qualification/calibration/validation studies in compliance with GMP,
- Finalization, control and submit to the approval of the qualification/calibration/validation reports related to all processes,
- Participating and supervising the studies in cases where the qualification/calibration/validation activities are carried out by an external company,
- To providing the preparation of Quality Management Systems (ISO 9001, ISO 13485) related documents, to provide organization, monitoring and control for the realization of activities,
- Supporting the management of processes (deviation, change control, corrective-preventive action, customer complaints, GAP analysis) carried out within the scope of GMP compliance,
- To providing the necessary organization to meet the regulation origin demands requested by the customer companies,
- Preparing or revising the Production Protocol,
- Support by participating in GMP audits, preparation of CAPA plans and follow-up of audit actions,
- Following the supplier qualification management process, participating in audits and preparing audit reports.
