1.To review Finished Product Specification, Raw Material Specification, Packing Material Specification & Method of Analysis of products for P2P products.
2.To review and approve Finished Product Specification, Raw Material Specification, Packing Material Specification & Method of Analysis of products for LL products.
3.To prepare and review Quality System Formats, SOPs, Specifications, MOAs to different LL manufacturing sites.
4.To prepare and review Quality agreements for LL and P2P mfg. sites.
5.To review BMR and BPR of LL products manufactured at Contract manufacturing sites by visiting monthly basis.
6.To review quality documents of all existing LL / P2P contract manufacturing site.
7.To obtain Technical documents like Manufacturing / Product licenses, GMP Certificates, Stability Data, Finished Product COAs, Process & Analytical Raw Data from existing manufacturing sites.
8.To prepare stability protocol to LL contract manufacturing site QA.
9.To perform routine GMP audit of existing LL/P2P contract manufacturing sites and ensure compliance.
10.To coordinate with LL product manufacturing site QA for Finished Product COAs before dispatch of products from respective sites and COAs of first three consecutive batches manufactured at P2P sites.
11.To assist in verifying randomly the export consignments and batch documents prior to dispatch of product from LL contract manufacturing site.
12.To prepare and follow up with site QA for customer / authority audit compliance report from the respective LL site.
13.To review quality documents like specifications, COAs, SMF, Stability Data and FPS etc. obtained from outsourcing / marketing departments for new product and new site introduced by them.
14.To prepare, record and support for closer/compliance of Market Complaints, OOS, Deviations, Incedent/investigation reports with contract site.
15.To coordinate with RA to resolve query raised by Local authorities, customers and Regulatory authorities.
16.To review and approve artworks for Domestic and Export markets for LL/P2P products.
5.Major Challenges(in the company/department): Candidate must be ready to travel extensively to audit third party formulation sites.