Description:
Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements; reviews/analyzes data and documentation. May require an advanced degree and 3-5 years of direct experience in the field. Familiar with a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. A wide degree of creativity in problem solving and latitude is expected.
Perform compliance activities of complex nature as per schedule and per standards/SOPs and act as resource of knowledge and expertise of other members of compliance team. Key fields include Risk Management, Change Control, Annual Product Review (APR), Audit, Gap Assessments, Regulatory documentation (Submissions, Re-registrations, market extensions, responses), external standards and the Novartis Quality Manual
• Proven high level of integrity and desire to comply with regulations and standards.
• Extensive knowledge of cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices.
• Must demonstrate superior verbal and written communications and interpersonal skills
• Appropriately allocates effort among several goals, with a high degree of independence and may allocate activities as a learning point for team members with over site
• Exhibits sound judgment by evaluating problems thoroughly, soliciting input and ideas, and using a systematic decision making approach.
• High understanding of the relationships between Manufacturing, Quality Control, Quality Assurance, Compliance, R & D and Regulatory Affairs.
• Review investigative testing to support laboratory investigations; participate in root cause analysis
• Conduct peer review and approval of documentation produced by co-workers and provide feedback or coaching on how to improve
• Lead compliance initiatives/projects or programs
• Good working knowledge of statistics
Bachelor's Degree
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