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: Manager Quality Assurance
Job Description:
The purpose of this role is to manage overall Quality and Compliance activities of product development life cycle & to support Product Sustainment team to ensure related practices adhere to market(s) Health Authority regulatory requirements & Novartis Corporate GMP Quality Manuals. In addition, to ensure Product Sustainment development activities are in compliance with regulations. Provide QA / Compliance support for product sustainment team relaunches & for new product launches. Implement and maintain Novartis GMP Quality Manual Lead Quality Systems from compliance perspective in order to establish appropriate corrective and preventative actions. Provide support during internal and external (HA) audits and ensure all corrective actions are addressed as per designated timelines. Support product sustainment team in development activities from compliance perspective to ensure the product is relaunched successfully in the appropriate market as per timelines & meeting all regularory requirements.
Candidate Profile:
Minimum Bachelor of Science in Pharmacy, Chemistry, or other Scientific Disciplines English
• At least 8 years experience in the pharmaceutical, consumer health, or medical device industry in the areas of manufac-turing, quality and regulatory systems, process development.
• QA and cGMP experience in Pharmaceutical, GMP and regulatory (GxPs) requirements including auditing and inspection against regulatory / quality standards.
• Demonstrated experience in managing multiple projects and deadlines.
• Good communication, planning, and organization skills.
• In depth understanding of pharmaceutical manufacturing, regulatory constraints, validation and product development.
• Excellent analytical, organizational, and problem solving skills.
• Good knowledge of computer systems, i.e. Microsoft, Word, Excel & PowerPoint.
• Demonstrated understanding best pharmaceutical industry practices, cGMPs, and Quality Assurance and Regulatory.
• Team oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity and communication. Must be adaptable to a diversified working environment. Experience in third party contract operations is preferred.
Additional Information:
Job ID: 122160BR
Experience: Min. 8 Years
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 25th July, 2013
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