 Releasing or rejecting all APIs. Releasing or rejecting intermediates for use outside the control of the company. Reviewing completed batch production and laboratory control records of critical process steps before release of the Products for distribution. Making sure that critical deviations are investigated and resolved. Approving all specifications, Master documents, executed documents, reports and records. Approving all Standard Operating Procedures impacting the quality of intermediates or APIs Making sure that Internal Audits (self-inspections) are performed. Approving Intermediate Contract manufacturers. Approving changes that potentially impact intermediate or API quality, via Change Control procedure. Review and approval of Validation and Qualification protocols and reports. Making sure that quality related complaints are investigated and resolved. Making sure that effective systems are used for maintaining and calibrating critical equipments. Making sure that quality related Market complaints are investigated and resolved.  To handle Returned Goods and follow up activities like Corrective and Preventive Action are reviewed and complied according to sop.  To monitor all activities of Re-processing and Re-working. To evaluate Quality related Risk Assessment.  Making sure that there is stability data to support, retest or expiry dates and storage conditions on APIs and/ or intermediates where appropriate. Review system related documents and ensure implementation of system.  To prepare Site Master File (SMF), Validation Master Plan. To conduct quality agreement activity for out sourcing facility.  Review of Annual Product Quality Review of manufactured APIs and intermediates  Making sure that quality related Out Of Specification and Lab Incidents are investigated and resolved. Vendor Audits. To arrange and conduct Training on cGMP, SOP and evolution of the training and its effectiveness.