Aqa Associate
3 months ago
Mentioned skills needed for the Open position:
- Analytical Techniques understanding (HPLC, ELISA, TOC, Glycan etc.). Hands on experiences is preferred in the mentioned techniques as part of QC or R&D.
- Analytical QA experience for at least 3 years.
- Experience in facing FDA/EMEA/EU audit and Drafting Regulatory Queries response.
- Review skills of BAR (Batch analytical record), Incidents, Change control, OOS and CAPA etc.
- Skills in performing audit trail of QC instruments like HPLC, PCR, CE, plate reader etc.
- Very good understanding of SAP and SAP handling
- Experience in LIMS for analytical date review/Stability data review.
- Good understanding of SOP, STP, specification etc
**Qualifications**
MSc with 4 to 10 years experience into Quality
