Saif Ullah Email & Phone Number

Toronto, Canada Area

• Prepared Method Validation Protocols, Method Development, and Method Validation summary reports (focusing on organic volatile impurities and related compounds by GC)• Reviewed the DMF and evaluated analytical methods• Reviewed analytical documentation prepared by other analysts for accuracy and completeness• Trained new analysts within the Analytical Development LaboratoryDeveloped, validated and applied analytical methods in compliance with current Compendia Pharmacopeia, ICH and GMP requirements.• Performed physical and chemical characterization of drug substance and drug products and their related compounds.• Performed troubleshooting of complex issues with respect to the stability of the drug substances and drug products with the guidance of Scientist. • Performed testing and evaluation of R&D samples in support of specification development and NPD process.• Developed stability indicative analytical method for drug substance and drug products.• Prepared draft methods and method validation protocols.• Performed validation of analytical testing methods for drug substance and drug product including dissolution methods.• Evaluated the stability performance of trial formulations under forced degradation conditions with comparison of reference product.• Provide justification for specification limit of degradation products based on ICH guideline, stability data and compendia requirement.• Document, interpret and report results according to established SOP’s.

Toronto, Canada Area

• Performed Investigation/Evaluation of Analytical methods for Assay, Related Compounds and Residual solvents. • Performed validation of analytical methods for Assay, Related Compounds, Residual Solvents and Dissolution.• Perform chemical and physical testing of pharmaceutical products and raw materials.• Perform release tests for bio batches and initial tests for stability batches and other testing for submission.• Released drug substance material for manufacture of submission batches.

Lahore, Pakistan

• Coordinated daily Laboratory work for compliance with cGMP, GLP, SOPs, GQP, CAP, MTD, Safety Health and Environment guidelines.• Planning and executing analytical activities; analytical method evaluation and Validation. Analysis of raw materials and finished product, In-process materials/Stability studies. • Coordinated test method transfers, analyzing and interpreting final results from the results given by chemists on various tests.• Provided technical support for troubleshooting problems with testing methods and instruments.• Provided On Job training to new and existing Chemists.• Performed Investigation on OOS and OOT results.• Reviewed laboratory data in compliance with specification results.• Authorized the release of raw materials and finished products.

Lahore, Pakistan

• Performed Investigation and Evaluation of analytical testing procedures and provided supervision to the junior staff.• Performed method Development/validation for analytical test procedures.• Reviewed the test analysis records for individual batch testing and validation data for analytical methods, provided training to junior chemists.• Conducted Stability studies and trend charting.• Maintained inventory for Chemicals, HPLC/GC columns, analytical working standards, spare parts for the instruments.

Lahore, Pakistan

• Release testing of raw materials, drug products using wet chemistry techniques according to USP/BP and in-house procedures.• Performed analysis of drug substances, Finished products, In-process materials, Intermediates, using HPLC, GC, Dissolution, UV-VIS spectrophotometer, FTIR, Karl Fisher Titrator.• Performed validation of analytical methods for Assay, Related compounds, Dissolution and OVI/Residual Solvents.