Research Scientist

2 weeks ago


Ahmedabad, India Zydus Group Full time

Department
- PTC - MORAIYA
- Job posted on
- Jul 26, 2023
- Employment type
- P-P6-Probationer-R&D Executive

**Position**: Reviewer
- ADL-EMB/SA/AHL/Australia/UAE/Saudi/China

**Location -** PTC Moraiya
- Preparation and review of test methods, method development reports, validation protocols and reports, method transfer documents, stability protocols & reports, CDP report & CoA
- Good hand of review the all ADL generated documents & good data record system (Raw data of routine work, MDR/DDR/CDP report /COA and other regulatory submission docs etc)
- Method development of Oral dosage form and Injectable formulations products etc. including characterization activity as per regulatory guideline.
- Validation and Verification of analytical methods (Assay, RS, Dissolution, Swab, Identification, Residual solvents, PSD etc.) and Pharmacopial compliance study
- Knowledge and handling of analytical instruments like HPLC, UPLC, GC, IR, UV-VIS ,XRD, Hardness Spectrophotometer, Particle Size Analyzer, Dissolution apparatus.
- Expertise on DMF technical review evolution on necessary section during API/Vendor qualification which is required for new dossier submission/filing as well as deficiency response to IRA as per timeline
- Co-ordinate with QC/Validation cell for analytical method verification and validation activity as well as report preparation
- Co-ordinate with Spec Cell/FnD/DQA/IRA for drug substance and drug product specification preparation as per current regulatory requirement
- Relationship building, to provide analytical support to formulation and development team, to arrange approval of development reports from DQA/CQA, to set drug substance and drug product specification by co-ordination with regulatory affairs department.



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