Develop and execute quality and compliance monitoring activities for PS processes within area of expertise to support a robust GVP Quality Management System.
Develop and present key Competitive Intelligence deliverables for multiple internal business partners, primarily R&D, Commercial, and Legal stakeholders
Candidate should be capable of operating Analytical instruments such as HPLC, GC,Dissolution Appratus, UV, IR, KF etc. should be aware and capable of Qualitative, Quantitative, Sample, Wet, Routine analysis of drug substances, intermediates, finished products, raw materials etc.
Supports to the Laboratory functions to handle Investigations, Deviation Management, Specifications ,test methods, method validations equipment qualifications ,internal audits and escalations if any.
Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required.