Cirrus Pharmaceuticals

Cirrus Pharmaceuticals is a contract research organization that aspires to be the first choice strategic partner for pharmaceutical and biopharmaceutical companies worldwide. With a combination of scientific expertise and timely delivery of quality services Cirrus is proud to have the highest rates of customer satisfaction. If you would like to joi... n a team where quality is paramount, please read on. We're seeking a Sr. Associate, Quality Assurance, to be responsible for QA oversight and release officer responsibilities to support the company's clinical trial manufacture. The Sr. Associate will be responsible for the day-to-day Quality activities needed to support the company's GMP manufacture, including review and approval of GMP documentation, quality record review and closure, and will work closely with the company's manufacturing team to ensure a quality and safe product. Additional Responsibilities are as follows: Release of Clinical Trial Supplies for human use Reviewing and approving executed Batch Records and associated GMP documentation Reviewing Analytical Documentation such as specifications, project notebooks, cleaning validation reports, method validation protocols, etc. Release of raw materials and packaging components for use Leading deviation and product quality investigations using effective root cause analysis methodology Managing CAPAs, Change Controls, OOS and Laboratory Investigations to timely closure Writing and editing SOPs to ensure compliance with applicable regulations Maintaining GMP compliance of the clinical trial manufacturing suite Experience working on continuous improvement projectsRead More