Senior Executive Quality Assurance

Job Description

Job Description Position : Senior Executive Quality Assurance Section : Quality Assurance Grade/Band : 1C Qualification : M.Sc. /B. Pharm. Desirable Experience: 06 - 10 years Followings will be the responsibilities of the position holder: To ensure effective implementation of system and procedure as per cGMP, cGLP and other Regulatory requirements, and monitor its compliance in laboratory. To participate in investigation of laboratory error report, incidents, out of trend and out of specification results and review the investigation report. To handle & coordinate QMS through SolTRAQs. To ensure the effective implementation of QMS through SolTRAQs application system. To participate in investigation exceptions, market complaints and out of specification results and review the investigation report. To act as a laboratory compliance administrator for creation of new users and projects and to review the audit trials. Compliance of QMS related SOPs and records. Ensuring the Compliance to EPD Global Guidelines. Facing internal and external audits and ensuring compliance. Implementation of GLP / GMP requirements. Coordinating and aligning the practices and procedures in line with the COBC requirements. Any other task assigned by reporting manager. JOB FAMILY: Operations Quality t