Senior Quality Assurance Specialist

Sanofi Sağlık Ürünleri

Key Responsibilities

• Providing checking the production and analysis records related to the produced batches in accordance with cGMP rules and the data in registration file have been carried out and implementing batch release or rejection without any influence of any organization.
• Controlling, archiving formula and batch records according to cGMP/ ISO9001/ISO27001 rules and providing, sending the batch records to the related companies.
• Working with the relevant departments in managing all deviations and out of specifications within the Quality Assurance System, follows up the action plans and makes proposals about the system improvement. Takes the required measures upon the improvement of the system with the relevant departments.
• Evaluation of customer complaints and finalising them and taking actions to prevent re-occurrence.
• Ensuring the preparation of annual product review reports and makes proposals by determining the corrective and preventive improvement activities with the relevant departments according to the results of this review, in case of need and participates in the works to put them into effect.
• Attending GMP/ISO 9001 Quality Management System self-inspections, reporting and following the CAPA plan.
• Preparing/Revising the standard operating procedures related with the department.
• Preparing and submitting monthly reports and RFT data and KPIs for customers.
• Providing technical support to company personnel for the studies he/she perform.
• Contributing the studies to comply with the department budget and targets.
• Supporting the preparation and development of ISO 9001, ISO 14001 and OHSAS 18001 quality, environment, occupational health, and safety management systems and performing the applications.
• Participate in preparation of customer or authority audits to be performed in the facility, attending the audits, preparing the CAPA plan related to the department after the audit and performing the actions according to due date.
• Contributing to the risk analysis studies during production, analysis, and other processes.

Requirements & Qualifications

• University education in Chemistry, Chemical Engineering, and Pharmacy Faculty,
• Minimum 5 years of experience in QA department,
• Minimum 3 years of experience in people management,
• Knowledge with GMP and GLP requirements,
• Able to use MS Office, LIMS, and SAP effectively,
• Fluent in English both oral and verbal,
• Commit to customers, team oriented, results-focused, good communication skills.