Implementation of Quality systems in site.
Ensure compliance of statutory and regulatory requirements in site.
Ensure compliance of regulatory audits and customer audits.
Review and upgradation of existing process in terms of reduction of time cycle, raw material controls, effective recoveries, product yields, product quality and services.
Ensure implementation of new products from R&D to pilot scale and pilot to plant scale of operations with designing appropriate equipment, better process controls & operations and safety aspects of the process.
Ensure design and installation of new equipments to meet the new process implementation.
Ensure design and provision of Utilities and Services and its effective utilization.
Responsible for implementing as per the inference obtained in production review & QA meetings.
Coordinating with departments for day-to-day process requirements.
Reviewing monthly, performance/activities of the departments for management information system.
Ensure implementation the corrective action as specified in audits.
Approval of SOPs, STPs, BPRs, Batch packaging records, Master formula, APQRs and equipment qualifications / process validations, validation master plan and training evaluations.
Review and authorization of Quality System Manual.
Authorization of approved BPR for production release.
Approval of contract agreements.
Approving of change controls.
Approval of deviations.
Coordinating with concerned Departmental heads on customer complaints.
Formation of coordination committee for product recall and authorization for disposal/reprocess of recalled material.
Approval of regulatory documents.
Authorization of customer agreements.
Approval of departmental requirements. Approval of indents, quotation comparative statements.
Conducting internal audits and reporting to Management.
Chairing safety committee meeting.
Coordinating with management and departmental Heads in management review meeting.
Approving stability summary reports.