Job Details:
1.Review of Pre-technical documents received from R&D or Contract giver.
2.Evaluation of Gap Analysis in view of production feasibility, Equipment and requirement of procedure in consultation with subject of various functions.
3.Co-ordination between production and other department namely R&D, QA, QC and warehouse etc.
4.Review of new product handling in existing facility with respect to environment, Health & safety prospective conjunction with EHS & Engineering department.
5.Co-ordinate between production and other departments for preparation of MFR, BMR, BPR, PEP / PVP & PER /PVR & document control to support production activities.
6.Preparation of RM, PPM BOM and review of SPM BOM. Co-ordinate for trail batches, optimization batches, exhibit batches and initial commercial batches (Process validation).
7.To assist QA during regulatory submission with respect to Tech- Transfer documentation. Execution of Process validation.
8.To ensure the availability of all pre-requisites to execute new products.
9.To involve the new product execution along with R&D & new product execution for contract giver & to import training to subordinates.
10.To assist for documents such as SOPs, qualification & validation documents, QMS Activities change controls, deviations, investigations and CAPAs. Any additional activities given by superiors as per requirements
If you have relevant experience please share your CVs on below given mail id: