Expert Stability

Expert Stability

Teva

Sofia, Bulgaria

How you’ll spend your day

Stability:

• Support in activities related to Studies performed during stability control including studies performed in internal Teva sites or external studies performed in Vendor’s or contract labs.

Support within EMSO Quality EMEA:

• Support in obtaining of product-related reports to QA/QPs or team leaders in case of quality deviations during the active stability studies in order to take decisions with regard to usage, necessary actions for product optimization and variations if applicable in collaboration with Quality Compliance team.

Audits/inspections:

• Participation in the preparation of the department for audits and inspections.

Change Control/Compliance:

• Support in ensuring of change control process with regards to stability where applicable.

Tech transfer/switches/launches:

• Support during processes of transfers, switches and launches of the product with regards of ensuring high quality of the product.

Assurance of pharmaceutical quality:

• Support in processing of critical quality issues aroused during inspections at manufacturers or stability. Support for evaluation and examination of affected products and quality issues in close cooperation with QA/QP.

Projects:

• Assistance in realization of global projects at EMSO with respect to stability for quality services. Support the team leaders and qualified persons in the development of adequate concepts to meet project objectives and time lines Processing of resulting tasks inclusive of monitoring and communication of project progress.

Cost Control:

• Support in requesting of stability related POs for Quality services and following activities in accordance with internal approved processes and guidelines.

PQRs:

• Support to the relevant team for the periodical evaluation with regard to the PQR process and of KPIs.

Your experience and qualifications

• Master's degree, preferably in Chemistry, Pharmacy, or related natural sciences;
• Preferably 2+ years experience in the field of quality control with regard to Stability testing;
• Knowledge about analytical methods and technics;
• Knowledge of production steps and the resulting manufacturing descriptions;
• Good software knowledge of MS-Office, SAP Business Warehouse and Trackwise;
• Good command of the written and spoken English language;
• Good communication and relationship skills;
• Ability to solve problems.

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