- To Lead the Vendor Management related activities including qualification of Vendors, Service Providers, Contract Manufacturing and Contract Testing Laboratories across R&D;, API and Formulation units of Biological E, pharma divisions.
- To participate in an In office audits as part of vendor audits, contract testing laboratories, contract manufacturing and external service vendors qualifications.
- To approve all Vendor Management related activities including qualification of Vendors, Service Providers, Contract Manufacturing and Contract Testing Laboratories across API and Formulation units of Biological E, pharma divisions.
- To Review and approve of Quality Management Systems (QMS), including Change controls, Deviations, Investigation reports and CAPAs.
- To review and approve Risk assessments related to Vendor, Contract Testing Laboratories and Contract Manufacturing and Service Provider qualification related activities.
- To approval of Quality agreements & Technical agreements.
- To provide remediation plans for the audit observations, if any
- To provide support / relevant information to the customers / suppliers as per the requirement.
- To Lead the self-inspection audits including schedule, participation in the self-inspections and approve the Self-Inspection reports/ relevant documents as applicable.
- To review the performance of quality system through review of QMS documents and present the data during site Management Review Meeting.
- To coordinate and support Site quality management during audits by consultants, external audits, regulatory audits etc.
- To participate in the Customer and Regulatory audits as per the requirements.
- Impart the training sessions to the concerned personnel on cGMP, compliance, regulatory updates and to improve awareness at operator or analyst level.
- To review and assess the effectiveness of system changes and adequacy of CAPAs and post closure effectiveness checks.
- To review and assess the Health authorities observations at the Site and R&D; and verify the compliance.
- To coordinate with the team for approval of SOPs pertaining to quality system design and associated controls.
- To Train and qualify the Quality Auditors on Auditing Skills.