Career for Lead-TRD QA in Novartis

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Lead-TRD QA, India

Job Description:
The Head/ Lead for TRD QA, India leads the TRD QA India team ensuring optimal execution of assigned business deliverables and the development and implementation of Dev. QA overall strategic vision. Drives quality and compliance across the TRD functions in India; to ensure on-going compliance with regulations, Heath Authorities expectations and Novartis policies and standards. Actively participate in defining of the global TRD QA strategy and define the strategy for TRD QA India operations, in close collaboration with other members of the TRD QA LT and site Development leadership team. Lead multiple TRD QA operations at different locations connected with TRD India operations in order to ensure TRD and TRD QA’s objectives are met and quality and compliance goals are achieved in all our operations in India. Achieve and promote a culture of Quality, high performance and trust. Ensure that the most talented associates in the industry are hired, developed and retained and that succession plans for key positions are in place; so as to have an effective organization structure to meet business and quality requirements. Ensure that Novartis Quality policies, standards and systems are fully implemented and meet internal and external (local and global health authority’s) expectations. Strive for a balance between high scientific and regulatory standards. Work directly with TRD Line Units to provide quality oversight on a continuing basis and to provide expertise and guidance in interpreting applicable Novartis standards, policies and / or health agency regulations and guidelines to assure compliance. Contribute to the development and operational excellence of the TRD India organization through a leadership role and influence on the TRD India management team. Contribute to continuous improvement in all TRD India operations to optimize efficiency and effectiveness in quality and speed. Lead audits and inspection preparations, resolution of audit and inspection findings in TRD India functions. Represent TRD QA India in all TRD India sites’ audits, inspections and regulatory interactions. Adhere to Novartis values and behavior in particular to ethical, safety, HSE and information security standards.

Candiate Profile
Post graduate in Life Sciences / Chemistry / Biochemistry / Biochemical engineering. Fluency in English as a business language (oral and written) Minimum 10 years’ experience in pharmaceutical QA/QC, with at least 5 years in a leadership role. Proven ability in leading and influencing people through excellent management skills. Excellent communication and negotiation skills. Demonstrated ability to effectively lead interdisciplinary and multicultural teams and to interact in a global, interdisciplinary and multicultural environment. Excellent knowledge of cGMP requirements of major health authority bodies, with experience in areas of laboratory testing, stability testing, analytical method validation, formulation development, clinical packaging and instrument qualification.

Additional Information:
Experience: Min. 5 Years
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Division: Pharma
Job Type: Full Time
Employment Type: Regular
Job ID: 126131BR
End Date: 13^th Feb, 2014