About the Job:
DGM Process R&D
Lead the group of Synthetic Architects/Scientists at locales for Tech ingestion and Move
Perform Cycle Scale up examinations in Lab/CPP to lay out a powerful cycle for preliminary and approvals for tech move and scale-up action..
Suggest the right hardware for increase and offer help in the execution of scale up clumps at CPP.
Map the hardware depends on the volume estimations from Kilo lab and lab information.
Set up the BPR, BOM and recipe and guarantee their endorsement for bunch fire up.
Guaranteeing the office preparation regarding tidiness, temperature clear preliminaries, gear inhabitance and so on.
Support in performing Office and Cycle Wellbeing Examination by leading PHA and PSI, which incorporates Consider the possibility that, HAZOP concentrates by organizing with all Cft's.
Arrangement/survey of MFD, PFD, P&id's, BPR and Utility estimation collaborating with Cft's.
Offering Specialized help during Occurrence Examination of group disappointments to find out and dispose of underlying drivers.
Including in new cycle gear acquirement by planning/audit URS, Undertaking costing and essential PFD and offering help during hardware establishment and capability.
Giving preparation to the creation faculty prior to beginning the new cycles at CPP. This preparing incorporates Security, Quality, Basic boundaries, Cycle and Item Data.
Ought to have adequate openness on actual trademark assessment of APIs, including PSD, surface region and so on.
Executive - QC
To acquire the research center principles as indicated by the necessities.
Investigation of completed item and dependability tests.
Day to day work portion in view of month to month and everyday timetable.
To receipt of all lab standard and keeping up with the stock, records and naming as indicated by the method.
Capability of Working Norms and the executives of Research center principles (Like - Reference Guidelines/Essential Guidelines/Adjustment Guidelines, and so forth) in QC Lab.
Commencement of progress control, Lab occasion, deviation and so forth in track wise.
To performed occasionally Adjustment, Preventive upkeep, Execution confirmation and Capability of instruments.
Issuance and getting of HPLC/GC Section.
Raising of the work demand in SAP for Breakdown of instrument/hardware/region, keeping up with temp/RH and so on.
Day to day recording of Temperature and RH (Testo Saveris) of QC research center (counting fridge, Dee cooler).
Liable for trustworthiness, exactness and ampleness of the examination performed.
To qualify the Functioning Standard vials for routine use, issuance and Annihilation of a similar after the legitimacy and keep up with the records.
Occasional audit and Check of existing stock against the most recent inventory of separate pharmacopeia.
To guarantee annihilation of terminated norms according to SOPs.
Start deviation, lab occasion, OOS in track wise and take part in examination.
To take part and contribute in inward and outside Reviews.
Guarantee chronicled of all kind of records connected with Quality control division.
Keep Logical information in SAP and Planning of Testament of examination.
To follow and guarantee consistence to cGMP and EHS norms in the QC laboratory