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Post: Sr Mgr QA-Global Dev QA
Job Description
Assist the Head Global Development QA- Hyderabad in the development and implementation of Dev. QA overall strategic vision, development & implementation Quality systems and governance for global Pharma Development, Oncology and GMO functions that are consistent with Health Authority regulations/ expectations and Novartis’ policies and standards.
- Assist in driving quality and compliance across the Hyderabad Development site & organization to ensure on-going compliance with regulations, Health Authorities expectations and Novartis polices and standards
- Assist in the implementation of Quality culture in the Development functions in Hyderabad through attention to quality and regulatory compliance via training and integration with groups - Participates in the defining and assisting in the implementation of the Hyderabad Development Quality objectives/ strategies and Quality Plans across line functions at the site
- Assist in the identification of areas of potential Quality risks and compliance issues, assist in the monitoring the overall status of quality and compliance within Hyderabad Development on an on-going basis and escalates issues to Senior Management, as appropriate; manage a risk profile for the site.
- Lead identified work streams for risk assessments and risk mitigation plan implementation across Development functions at the site to ensure that Hyderabad Development is in a state of inspection readiness for regulatory inspections and Group audits
- Assist in the development of adequate key quality and performance indicators are defined and implemented, regularly reviewed with Hyderabad Development and Quality management (QRB) and adequate action plans defined and implemented, as appropriate.
- Collaborate closely with Global Dev. QA groups and Development functions and stakeholders in the development & implementation of procedures, training modules, CAPA monitoring processes, risk assessments, KPIs/ KQIs etc. for line functions at the site.
- Implementation of Novartis Quality Manual assuring GXP- and quality responsibilities are clearly defined; Performs change control and check of regulatory compliance, as needed and appropriate at the site
Candidate Profile
Master’s degree in Science or Advanced courses after bachelors’ degree. Fluency in English (oral and written)
• 8-10 years of experience in pharmaceutical de-velopment and working in a GxP regulated area (especially GMP or GCP); broad understanding of global expectations of Health Authorities in the area of Pharma Development.
• Experience in preparation, development and ad-ministration of SOPs and quality systems
• Demonstrated leadership in implementing robust quality systems in a regulated area
• Strong interpersonal, communication, negotiation and problem solving skills; strong project man-agement skills
• Considerable organization awareness (e.g. interre-lationship of departments, business priorities), in-cluding significant experience working cross-functionally and in global teams
Additional Information:
Job ID: 140622BR
Experience: 8-10 Year
Qualification: M.Pharm, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
Location: Hyderabad
End Date: 30th April, 2014
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