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Position Responsibilities & Accountabilities

Technical Responsibilities

·       During Project Phase: Implementation of Manufacturing Execution System (MES) with regards to QM processes, including 'Review by Exception RbE' concept during the project phase

·       Implementation and Maintenance of Quality processes for Review / Approval of master batch records/ executed batch records including writing of relevant procedures during the project phase.

·       Review and release of purchased materials, internally manufactured materials including buffer/media assemblies, intermediates and drug substance including writing of relevant procedures during the project phase.

·       Review and approval of operational elements such as procedures and related documents including specifications

·       Assist with continuous improvement initiatives related to quality documents and processes.

·       Supervision of the preparation of the Annual Product Review (APQR) and guarantees its execution within the due date.

Quality

·       Adheres to general cGMP rules, Quality policies, porcedures and instruction as rolled out by the Quality function and endorsed by the site management.

·       Actively contributes to continuous quality improvement initiatives and deviation reporting and follow-up.

EHSS

·       Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management.

·       Actively contributes to safety initiatives and issues as well as near miss reporting and follow-up.

Values and behaviour

·       Maintains commitment to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards.

·       Takes personal accountability for his/her presence, performance, and productivity for the achievements of defined objectives.

·       Thinks and acts with a customer-centric mindset.

·       Is intellectually curious and embraces Practical Process Improvement (PPI).

Position Qualifications

Education

·     Pharmacist, Chemist / Biologist / Microbiologist / Biochemist or Immunolgist with master degree or higher.

Experience & Competencies

·     3-5 years in pharmaceutical industry (biotech company) and not less than 1 year in commercial batch release

·     Knowledge of pharmaceutical manufacturing processes with particular focus on biologic drug substance

·     Fluent communication (oral and written) in German and English.

·     Experience in SAP and electronic MES (manufacturing execution system) is an asset

Please send your full application documents to [email protected]

Branche: Pharma-Industrie

Funktion: Qualitätsprüfung

Führungsperson: Nein

Anstellungsart: Festanstellung

Karrierestufe: Management