Job for Clinical QA Manager at Sandoz

 

 

At Novartis, we use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

Post : Clinical QA Manager

Job Description
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.
13. Collaborate with other Company departments involved in study activities.

Candidate Profile
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 thinking

Additional Information
Experience : 3 years
Qualification : B.Sc, B.Pharm
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th May, 2019

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