Quality Assurance Manager
Çerkezköy, TR
Job Purpose
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Ensuring the full and effective implementation of the requirements specified in the Guidelines for Good Manufacturing Practices (GMP) of the Ministry of Health and Pharmaceutical Products and in the European and Russian Guidelines, as well as of other applicable territories.
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Ensuring that a Quality Assurance system in accordance with the Official Regulations is established, for that purpose, ensuring that all the measures required for this purpose are taken correctly, at every stages of production, including pre-production, during production and storage after the production, retaining all necessary documents and establishing an effective control mechanism.
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Ensuring the correct organization of Quality System/GMP inspections made by the authorities (local and foreign) and audits made by customers, as well as of the auditing activities organized towards Contract Manufacturing Organizations that supply products to the Company, monitoring the results and ensuring that corrective actions are carried out on time.
Key Responsibilities
JOB DESCRIPTON:
- Applying the necessary Risk Assessment and Continuous Improvement principles to Quality activities according to the guidelines of Pharmaceutical Quality Systems of different territories.
- Providing GMP and technical training of Quality Assurance personnel continuously and adequately according to the approved program.
- Ensuring that all records and samples related to GMP documentation are properly maintained and stored.
- By assigning in-process controls jointly with Quality Control and Manufacturing, to supervise all manufacturing stages, to ensure that necessary corrections and/or corrective actions are made during manufacturing and to take initiatives to eliminate weak points.
Required Education
Graduated from Chemistry, Chemical Engineering and Pharmacy departments of universities
Required Skills and Experience
- At least 10-15 years of experience in the Pharmaceutical Industry
- Completed military service for male candidates
Technical Competencies
#LI-KL1
Required Behaviours and Competencies
- Effective communication and collaboration across teams and cultures
- Strong time management skills and discipline
- High planning and organizational skills
Required Languages
- Fluency in English (have good verbal an written communication skills)
Travel required in %
- No travel restrictions
- Residing in Tekirdag Çorlu, Çerkezköy, Kapakli, Ergene districts or Silivri-Büyükçekmece-Avcilar-Beylikdüzü or able to move in a short time.