Quality Control Specialist Pharmaceutical Operations
vor 1 Monat
We are seeking a Senior Scientist QA Operation to join our team.
Position Responsibilities & Accountabilities
Technical Responsibilities
• Implement and maintain Quality processes for Review / Approval of master batch records/ executed batch records, including the development of relevant procedures.
• Review and release of purchased materials, internally manufactured materials, including buffer/media assemblies, intermediates and drug substance, including the development of relevant procedures.
• 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.
• Supervise the preparation of the Annual Product Review (APQR) and ensure its execution within the due date.
Quality
• Adhere to general cGMP rules, quality policies, procedures, and instructions as rolled out by the Quality function and endorsed by the site management.
• Actively contribute to continuous quality improvement initiatives and deviation reporting and follow-up.
EHSS
• Adhere to general safety rules, policies, procedures, and instructions as rolled out by the EHSS functions and endorsed by the site management.
• Actively contribute to safety initiatives and issues as well as near miss reporting and follow-up.
Values and behaviour
• Maintain commitment to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards.
• Take personal accountability for his/her presence, performance, and productivity for the achievements of defined objectives.
• Think and act with a customer-centric mindset.
• Be intellectually curious and embrace Practical Process Improvement (PPI).
Position Qualifications
Education
• Pharmacist, Chemist / Biologist / Microbiologist / Biochemist or Immunologist 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.
We look forward to receiving your application documents.
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