Job Reference: JO-2106-65841_1623254194
The successful candidate will be required to perform QA review of production records & associated documents and QA review & approval of procedures and GMP deviations.
- Review and approval of change controls, observations/ deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
- Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility and Annual Product Reviews.
- Re-identification, re-evaluation & disposition of raw materials, intermediates and packaging components used in the manufacture of relevant pharmaceutical products where necessary.
- Batch disposition, including approval of batch records, for API and Intermediate batches & approval of CoA's.
- BSc, MSc, or PhD in Chemistry, Engineering or related discipline, with minimum 3 years relevant experience.
- Excellent attention to detail.
- Demonstrates ability in critical thinking, data analysis, problem solving and experience in root cause analysis.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists