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: Quality Manager II
Job Description:
The assessment, facilitation and verification of quality standards achieved within IT activity in a designated geographic/operational area in accordance with the requirements of Novartis corporately and any external legislative or regulatory requirements.
- Applies the specifications of the corporate and organizational Quality Systems and Quality standards to ensure that the quality of processes and deliverables of both, projects and services continuously meet their specified corporate and regulatory requirements.
Major Accountabilities:
- Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements.
- Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement.
- Follow up resolution of identified quality exposures and escalation to line management if critical situations are not resolved in due course.
- Drive shifting of emphasis from "final inspections" to "in-process reviews and controls".
- Contribute to business decisions in the definition and assessment of IT requirements.
- Support the development and delivery of training in quality matters.
- Drive and facilitate the creation of relevant SOPs.
- Interface with business and IT partners to ensure Novartis practices are aligned with regulatory expectations and industry best practices.
- Prepare and follow internal authority inspections.
- Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables.
- Coordinates documentation, testing, and change management activities to ensure compliance with business and regulatory needs.
- Partnering with Quality Assurance departments in order to align quality related processes and to achieve common agreement on standards.
Candidate Profile: 5 years of experience in an appropriate Quality area. Sound knowledge of Project and Quality Management methodologies, (e.g. Crystal, SDLC), reviews, and training.
Additional Information:
Location: Hyderabad
Education: B.Pharm/B.Sc, Any
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA/QC
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 101822BR
End Date: 17th Aug 2012
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