Glenmark is a leading player in the discovery of new molecules, both NCEs (new chemical entity) and NBEs (new biological entity), with multiple molecules in various stages of clinical development & pre- clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Lifesciences Limited markets APIs to regulated and semi-regulated countries.

POSITION SUMMARY:

The role involves support to various activities that are involved in Analytical Validations and Development process for Injectable dosage forms. The goal of this role is to deliver services with an accuracy in results and within agreed timelines set by Group leader.

JOB RESPONSIBILITIES:

Validation at R&D and site:

Act as SME and represent method validation Team in Internal and external audits

• Prepare and Review of method feasibility Protocol and summary Report as per guideline and regulatory requirement.
• Prepare and Review of method validation/verification Protocol and summary Report as per guideline and regulatory requirement.
• Coordination with R&D team for technical aspects related to products method development and validation.
• Coordination with QC/QA team for getting the review and approval of relevant documents related to method validation studies
• Support for method validation
• Coordination with R&D and QC for logistics / materials movement from Sister sites.
• Assist in Data integrity review of method validation data
• Assist in troubleshooting of instrument / equipment breakdowns

Documentation Review:

• Review of raw data generated for method validation
• Review of documents sent from Sister sites related to method validation and transfer.
• Author and/or Review of Documents in support of regulatory filings for NDA/ANDA products
• To follow current GLP System in the lab maintain the quality and accuracy of the work throughout the year

Education:

M.Pharm - Pharmaceutics Chemistry / Ph. D / M.Sc. Analytical Chemistry

Experience :

• Should have 15 to 20 years’ total work experience in Analytical Development and Analytical method validation

Knowledge and Skills:

• Should be well acquainted with handling below equipment like HPLC/UPLC, GC, UV Spectrophotometer, Particle Size Analyser, AAS, Autotritator etc.
• Communication and coordination with Cross functional team
• Experience in handling ANDA