AQA Associate
- Full-time
- Job Family: Analytics
- Sub Job Family: Data Sciences
- Preferred type of working: On-Premise
- Years of Experience: 6 - 12
- Business unit: Biologics
Company Description
Dr. Reddy Ltd
Job Description
The candidates shall be having industrial experience between 5 to 7 years and master qualification in the field of Biotechnology or Biochemistry.
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…
- Handling of QMS.
Qualifications
MSc with 5 to 7 years experience into biosimilar molecules
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