Job for Group Leader at Good Health Pharmaceuticals
Good Health Pharmaceuticals Pvt Ltd, is a research based pharmaceutical company currently focused on developing, 505.b.2 products and first to file complex generic products, which includes oral liquids/solids, injectable products and topical/dermal preparations.
Post : Group Leader, Analytical Development
Job Responsibilities & Required Skills
Manage a group of 4-6 direct reports with varying levels of experience and degrees in order to develop, establish and qualify analytical testing methodologies used to control raw materials, intermediates, and final products
1. Strong knowledge of regulatory requirements for the analytical methods for assay, related substances, dissolution, residual solvents and analytical tests pertaining to testing and release of pharmaceutical finished products intended for USA and European markets.
2. Hands on experience with HPLC, UPLC is must and experience with GC-FID, GC-MS, LC-MS and other high end analytical instruments is highly desirable.
3. Investigate and solve analytical technical issues related both raw material and finished product testing.
4. Clinically evaluate various compendial analytical methods if available and prepare list of pros and cons before going for implementation of methods for developmental projects.
5. Preparation of standalone protocols for method validations, verifications and stability testing in accordance with various international guidelines, compendial requirements and target market requirements.
6. Set general guidance document for preparation of method validation reports, thoroughly review validation reports prepared by fellow scientists in the lab.
7. Coordinate with scientist at various CRO’s and CMO’s in different countries for smooth transfer of analytical methods. Ensure successful execution of methods at CMO/CRO sites.
8. Train staff on analytical techniques and instrumentation.
9. Provide guidance to lab personnel on safe lab practices. Maintain analytical lab in compliance with GLP requirement.
M.Pharm/M.Sc in Analytical science with 8-10 years’ experience in reputed pharmaceutical company. PhD degree in relevant field is highly desirable.
Experience : 8-10 years
Qualification : M.Pharm/M.Sc
Location : 8-10 years
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Analytical Development
End Date : 30th April, 2019
Send you Resume : email@example.com
Dr. Basavaraj Siddalingappa
See All Other Jobs in our Database