Develop and implement the Quality Systems of the Company & products.
Plan and provide support to manufacturing activities as per Quality Management Systems (QMS) / GMP guidelines.
Ensure the preparedness of system/ records for external inspections/audits fro m regulatory agencies/certifying agencies.
Development of Quality Assurance systems for compliance of regulatory audits, continuous improvement with risk assessment and management.
Technical investigations, assessment of non-conformance's and its management by CAPA.
Review change control requests and deviations and analyze quality impact.
Design and implement validation master plan.
Monitor adherence to cGMP / Pharmacopoeia requirements;
Review and approve all documents for technology transfer and oversee execution of the process.
Develop & monitor sample management system for control samples, validation samples, stability
samples & market/customer samples.
Develop site master files and validation master plans of all sites.
Identify training needs of quality teams; Conduct GMP, GLP and other training programs for employees across levels and functions;
Provide strategic guidance to the teams which are responsible for dossier preparation / submissions, product approvals & registrations, compliance with policies and norms.
Train & develop team capability for operation & trouble shooting for advanced analytical instruments like HPLC, GC, FTIR & UV etc.
Handle the review & approval of specification for pharmaceutical ingredients and finished products; ensuring compliance with company standards.
Supervise & review achievements as well as monitor team performance.
Lead the quality audit process for new & existing - RM& PM vendors, contract manufacturing sites & third party sites.
Market complaints Investigation, CAPA analysis, resolution of complaints & taking timely corrective action.
Stability studies for all products (existing formulations & new formulations) as per FDA & internal guidelines and give feedback to the stakeholders.
Establish effective plans, quality systems & procedures to assure compliance with all applicable regulatory bodies.