Audits, vendor qualification / re-qualification and approval of vendors.
Auditing the manufacturing locations periodically to check the compliance of cGMP. Auditing of manufacturers of contract testing laboratories, LL/P2P facilities, third parties and ensure compliance.
Audit and approval of contract testing laboratories, LL/P2P and third party manufacturers.
Review and approval of technical agreements for contract testing laboratories, LL/P2P and third party manufacturers.
Review of Regulatory audits at Agio sites, third party or LL/P2P manufacturing sites in case of impact to product quality.
Technical support to Agio sites, third party or LL/P2P manufacturing sites as needed.
To review and monitor the quality management system at manufacturing location.
Responsible for the customer / Regulatory Authority audit compliance at site.
Responsible for planning, execution and compliance of internal audit.
Review and approval of Corporate Quality Assurance Guidelines based on the national and international Regulatory requirements.
Management and ensure implementation of Training on Data integrity, GMP & GDP etc.