Review of R&D documents such as stability data, Analytical reports, Method verification reports, Method validation protocols & reports, analytical data of pilot bio batches / DQ batches and Product development data for its adequacy.
M.Sc Chemistry, B.Pharm, M.Pharm ; Preparation of IPQA SOPs, IPQA Checks, AQL, Line Clearance, Review of BPR, Audit & Compliance, Sampling of API & Drug Product, Document & Data Control, Control Sample Management.
The person should require minimal guidance when determining methods and procedures on new assignments. Decisions often impact the team in which they reside and occasionally impact other teams.
Bachelors degree in Engineering (B.Tech/B.E.), Pharmacy (B.Pharma), Life Sciences, or a related discipline. A Masters degree such as M.Tech, M.Pharma, MBA, or equivalent is highly preferred
Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate
Supplier qualification: Ensures a valid Quality Agreement in line with the requirements of the Novartis global template is in place and continuously amended to the business needs.