Job Description
Role & responsibilities
Co-ordination with marketing team and PPIC team for releasing the PO to Out-sourcing site. Follow up with assigned outsourcing site for getting production plan and FG delivery schedule.
Frequent (monthly/ as per requirement) visit to outsourcing site for monitoring production and FG delivery & to ensure the cGMP & regulatory compliance.
Evaluation &/ approval of change control, deviation, BMR & BPR revision and investigation of market complaint.
Effective Inventory control by close monitoring materials procurements & timely consumption. Aging analysis of materials RM, PM, FG (Non Moving, Near Expiry etc). For RM/ PM having higher lead time to maintain minimum inventory / Safety stock. To review every 3 months the Safety stock of these materials & accordingly action plan.
Co-ordination and providing the technical documents to Outsourcing site, such BMR, BPR, MFR, Stability Protocol, FG Specification, RM / PM specification, SAP BOM, Hold time study protocol, PVP, PVR.
Co-ordination with our logistic team and outsourcing logistic team to move the FG for each consignment - arrange data logger, A/C vehicle, wooden pellets etc. To track & arrange invoice clearance through finance.
Co-ordination between vendor, Outsourcing site, PDC to get approval from regulatory for revised artwork & Shade cards.
Follow up and Receiving of Monthly statements from LL sites (Stock + Excise), posting the same in SAP (Materials Consumption + Excise part II). Follow up with the location to get the conversion bills in time, submitting to accounts for the payments as per 60 days credit limit.
Initiation & follow up & customer approvals for of Planned Deviation, Change control through EQMS (Till closure of Process / Documentation).
Co-ordination with vendor, contract manufacturing sites, Medreich PDC and customer for approval of revised artwork & shade cards.
Arranging of Working Standards, Reference Standards and impurity from in house Sites & Vendors (for QC analysis).
Follow-up with contract manufacturing sites for product license availability/obtaining as required.
In absence of Quality Assurance person, job description activity of quality assurance person will be carried out by concern Outsourcing Designee.