We are looking for Analytical QA experts from Biologics background with 5- 10 yrs exp. range.
Responsibilites / Expectations as below :
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…
Mail your applications with reevant subject (AQA) across ''[email protected]''
Sr. Executive in Analytical development
Location of the Job: Tandalja - R&D
1. Expertise in developing and characterising analytical methods for drug substances and drug products employing HPLC, GC, LCMS, GCMS, NMR, DSC, TGA, Raman Spectroscopy, and XRD.
2. Working knowledge of GMP environments for analytical method validations.
3. Skilled in preparing various protocols and reports and well-versed in regulatory needs and guidelines