GXP Process Expert
3 days ago
Job Description:
We are seeking a highly motivated and experienced Manufacturing Investigator to join our team at Zoetis Euafme. This critical role will involve leading investigations and improvement initiatives within manufacturing operations, ensuring compliance with regulatory requirements.
The successful candidate will possess expert knowledge of GXP manufacturing processes, with a strong understanding of cGDPs and cGMPs. They will be responsible for gathering data from various sources, performing root cause analysis, and identifying corrective and preventative actions.
This role requires strong analytical and problem-solving skills, with the ability to work effectively as part of a cross-functional team. The ideal candidate will also possess excellent technical writing skills, with the ability to translate complex scientific events into clear reports.
Key Responsibilities:
- Leading investigations and improvement initiatives
- Ensuring compliance with regulatory requirements
- Gathering data from various sources across the site
- Performing Root Cause Analysis (RCA) using tools such as fishbone diagrams and 5 Whys
- Identifying Corrective and Preventative Actions to reduce deviation recurrence
- Performing Risk Assessments, such as FMEA's
Requirements:
- BSc, MSc, or PhD in a relevant discipline (e.g. biochemistry, chemistry, process engineering)
- 2-5 years' relevant experience in bioprocess development and/or manufacturing
- Knowledge of Cell culture and protein purification
- Working in a controlled regulated environment (GMP/GLP)
- Experience working with external contractors
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