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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
266635BRClinical QA ManagerJob DescriptionExecute Sandoz SDC clinical QA oversight.Your responsibilities:1.Set up , implementation and maintenance of the SDC Clinical Quality Management System , to ensure compliance with GCP / GLP , local regulations; requirements and Company standards. 2.Ensure the appropriate trainings and awareness of quality and compliance requirements and the SDC Quality management System. 3.Support of SDC Clinical Operations function on implementation and proper execution of GCP / GLP quality related activities. 4.Lead / Participate in GCP audits in SDC. 5.Ensure SDC GCP inspection and audit readiness. 6.Escalate of high risk GCP areas and issues (including inspection announcements). 7.Plan and execute appropriate CQA review / assessments in SDC. 8.Oversight of local GCP Service Providers / clinical vendors to ensure their proper qualification to maintain Company standards. 9.Act as QARP or FURP in AQWA in the GCP audits of internal ClinOps or external clinical providers. Support in preparation , and follow up in implementation of appropriate corrective and preventive actions (CAPAs) from audits within ClinOps. 10.Prepare and follow up implementation of appropriate corrective and preventive actions (CAPAs) from audits in collaboration with ClinOps. 11.Ensure training matrices for ClinOps staff are in place and trainings executed accordingly. 12.Execute self - inspections of SDC Clinical Operations. 113. Collaborate with other Company departments involved in study activities.Minimum requirementsDesirable requirements:Graduate in Pharmacy , Life Sciences or Medical Science English fluent in speaking and writing At least 3 years experience in Clinical Operations or Clinical Quality Management Good knowledge of global regulatory framework , GCP experience , knowledge of EU and FDA and local regulations , ICH requirements and common quality standards Fundamental knowledge in pharmaceutical drug therapy (pharmacody - namics , pharmacokinetics) Experience in an international matrix organisation Good intercultural communication and negotiation skills Strong analytical and organizational skills Entrepreneurial , dedicated , inspiring , process and performance oriented personality with innovative and critical thinkingYou ll receive: (not mandatory)Breakdown of benefits received in this role. Include flexible working , learning and development opportunities as well. Why consider Novartis 817 million. That s how many lives our products touched in 2018. And while we re proud of that fact , in this world of digital and technological transformation , we must also ask ourselves this: how can we continue to improve and extend even more people s lives We believe the answers are found when curious , courageous and collaborative people like you are brought together in an inspiring environment. Where you re given opportunities to explore the power of digital and data. Where you re empowered to risk failure by taking smart risks , and where you re surrounded by people who share your determination to tackle the world s toughest medical challenges. We are Novartis. Join us and help us reimagine medicine.DivisionSANDOZ Business UnitProduct Dev SZ CountryIndia Work LocationHyderabad , AP Company / Legal EntityNov Hltcr Shared Services IndFunctional AreaQuality Job TypeFull TimeEmployment TypeRegular,
Keyskills :
inspectionautomationqualityegotiationskillmanagementsystemqualitymanagementsystemclinicalqualityserviceproviderslifesciencessharedservicesqualitystandardsqualitycontrolqualitymanagement