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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Ensure compliance to audits of Indian and international regulatory agencies as well as internal audits.
Ensure identification and remediation of gaps in site SOP s relative to Teva Corporate Policies and standards.
Maintain site s Quality Management System including but not limited to management of Events, Temporary Changes, Laboratory Investigations, Change Controls, Out of Specification, Deviations, Corrective and Preventative Actions, and Training and Qualification of personnel.
Release Pilot batches manufactured at Ambernath site and provide support for manufacture and release of submissions batches at the Teva Goa facility.
Exposure to quality assurance.
QualificationsUndergraduate BA/BS degree in Life Sciences or related field.
A minimum of 10 years of Experience in Quality Assurance and/or Quality Control within GMP setting.
Managerial knowledge of quality management system within the pharmaceutical industry.Knowledge of local (State FDA, CDSCO, DCGI) and international (ICH, USFDA, EMA) regulatory guidelines.
Experience with managing site inspections from regulatory bodies (India, USFDA, EMA).
,Keyskills :
quality management systemlife sciences internal auditquality control quality assurancemanagement system quality managementregula