Senior Supervisor, Analytical Development (Research)
Riyadh Pharma
مجموع سنوات الخبرة :23 years, 2 أشهر
Spearheading the overall Analytical Research & Development Division which including method developments, validation and stability studies
Inspecting the finished goods and establishing the methods for in-process monitoring and ensuring optimum quality
Assessing documents such as specifications and in-depth stability study reports
Reviewing:
o Drug master file (DMF) files from API suppliers
o Quality section of common technical document (CTD) for regulatory purpose
Interfacing the Regulatory Authorities on quality section of CTD on behalf of the company and resolving all concerns
Setting up the labs as per the guidelines pertaining to the cGMP system
Formulating policies and planning recommendations to the management for the Division guiding the stakeholders of action in operations by staff / employees
Managing resources, including instrument proposals and additional staffing, for ARD division
A skilled people manager; imparting training to technical staff on instrumentation, analytical methodology and ethical practices
Leading a team of Analytical scientist.
Method development for Assay, Dissolution and Impurity profiling.
Method Validation as per ICH guidelines
Maintenance of GLP and GMP system
Head- Analytical Development Laboratory
Analytical Support to NCE development and Pharmaceutical Product development
GLP study - Analytical Phase
Stability study for NCEs
Analytical Method validation and method transfer
Training and development
Impurity profiling
Method development for analytical and bio-analytical assay
Support to discover activity for purity screening, Impurity profiling and physio-chemical characterization.
Instrument calibration and Maintenance (HPLC< GC, DSC, FTIR)
5 years Integrated course (M.Sc.) with GPA of 6.5 Merit cum means scholarship recepient