QA &Compliance and release Specialist/Chemist
Delta Pharma
مجموع سنوات الخبرة :7 years, 3 أشهر
Operate the Change control system& Operate the CAPA system &Operate the Deviation system& Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs& Collaborate with other departments to create a culture of compliance& Assist in the gathering of internal information in response to regulatory requests& Conduct periodic internal reviews or audits to ensure that compliance procedures are followed& Identify compliance issues that require follow-up or investigation& Produce monthly key performance indicator (KPIs) on systems as Monitoring the manuf acturing process from dispensing of raw materials required stage to all preparation stages, packaging and storage of final product& Ensures Manufacturing Operations compliance with current Good Manufacturing Practices (cGMP), Company Standard Operating Procedures. (SOP)&Review of Batch record& Review of master records& Develop SOP & other GMP Controlled Documents& review artwork or any modification artwork of products& Assist and coordinate the preparation of reports in relation to Annual Product Reviews for products manufactured on site &Follow up all activities of process validation, cleaning validation, calibration