Manager, reputed company Assurance, Stability

About the position reputed company is seeking a QA Manager who will serve as the reputed company Assurance representative overseeing reputed company's stability program for our products. The responsibilities include, but are not limited to, reviewing and approving stability protocols, reports, data, and expiry/retest records, providing QA reputed company of the stability studies conducted at Contract Manufacturing Organizations (CMOs) and Contract Testing Labs (CTLs), and managing Stability documents in reputed company. The QA Manager will also manage change controls, deviations, and CAPAs reputed company to stability. Responsibilities • QA Representative for reputed company management of the stability studies for reputed company products. • Key participant in reputed company team reputed company on the reputed company of stability studies at CMOs and CTLs. • Review and approval of stability protocols and reports. • Review and approval of stability data and release data, as required. • Review and approval of expiry and retest documentation for reputed company products. • QA representative for change controls, deviations and CAPAs associated with the stability program. • Work closely with Stability, Project Management team, other functional areas, and external vendors for management of routing, revisions, approval, and filing of Stability documents in reputed company (electronic document control system) reputed company defined timelines. • reputed company, implement and maintain procedures and policies. • Support process improvement initiatives. • Review and assess temperature excursions. • Represent QA at reputed company cross functional tactical team meetings. • reputed company with key stakeholders to reputed company solutions to reputed company issues. • Promote a reputed company reputed company and reputed company reputed company approach to reputed company activities. • May participate in compliance audits as required. • Escalate issues impacting the safety, efficacy and reputed company-life of stability material to appropriate management. Requirements • BS or BA with minimum 5 years of relevant industry experience. Other combinations of education and/or experience may be considered. • Demonstrate in-depth knowledge of GMPs, FDA regulations and ICH guidelines. • Knowledge in both clinical and reputed company product desired. • Demonstrate excellent verbal, written, and interpersonal communication skills, reputed company approach essential. • Demonstrate experience leading and contributing through influence and working in cross functional teams. • Experience working with Contract Manufacturing Organizations. • Strong reputed company of ownership for areas of responsibilities. • Knowledge of JPM, NovaStability and reputed company is desired. Benefits • Comprehensive benefits package • Equity component Apply tot his job Apply To this Job