Quality Assurance Manager
(a) Authorize the release of Finished product to Market(b) Establishing a system to release or reject raw material, intermediates, packing and labeling material.(c) Reviewing completed batch production and laboratory control record of critical process steps before release of the AP/Excipient for distribution.(d) Making sure those critical deviation, change control, and OOS are investigated and resolved.(e) Handling of rejection of finished product.(f) Approving all… Show more (a) Authorize the release of Finished product to Market(b) Establishing a system to release or reject raw material, intermediates, packing and labeling material.(c) Reviewing completed batch production and laboratory control record of critical process steps before release of the AP/Excipient for distribution.(d) Making sure those critical deviation, change control, and OOS are investigated and resolved.(e) Handling of rejection of finished product.(f) Approving all specification and master production instructions.(g) Approving all procedures impacting the product quality.(h) Making sure those internal audits (Self-inspections)are performed.(i) Approving change that potentially impact on product quality.(j) Reviewing and approving validation protocols and reports.(k) Making sure that quality related complaints are investigated and resolved.(l) Making sure that effective system is used for the maintaining and calibrating critical equipment.(m) Performing product quality review.(n) Responsible for the control of issue and retrieval of quality documents.(o) Making sure that material are appropriately tested and results are reported.(p) Making sure that there is stability data to support retest or expiry date and storage condition on product where appropriate.(q) Making sure that Internal Audits (Self Inspection) performed as per approved schedule. Audit findings and CAPA documents completed in timely.(r) Making sure that Raw & Packing material supplier qualification and approval(s) To permit reprocessing of the product after through investigation.(t) GMP Training to all personals.(u) Reporting to Management on status & performance of quality management system & any need for improvement. Show less
