Audit and Compliance Professional

Major accountabilities:

• Planning and supporting PQR/APQR activities.
• Support site qualification and validation activities (planning, advising, review).
• Implementation of Quality Systems (incl. documentation management) -Supplier management activities (agreements, oversight, audit).
• Preparation/support and coordination of CAPA/follow-up -Audit and inspection preparation and support -Change control review/approval -Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc) -Ensure process quality assurance acc.
• to regulations -QP declaration review and approval -KPI trending -Ensure applications, certificate maintenance etc. to local HA -SPOC for communication with HA, GCA / One voice /consolidated approach / synergies for all sites within same HA jurisdiction / country -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Successful support of projects with agreed quality and delivery dates, passing of internal and external inspections.
• Meet quality and timelines for all projects -Act in accordance with Novartis standards.
• The number and severity of cGMP issues identified during internal and external audits -Year-end figures within budget; Successful coordination of departmental operational activities  

Minimum Requirements:
Work Experience:

• Functional Breadth.
• Collaborating across boundaries.
• Project Management.
• People Leadership.

Skills:

• Audit Management.
• Auditing.
• Communication Skills.
• Compliance Audits.
• Compliance Risk.
• Continuous Learning.
• Dealing With Ambiguity.
• Decision Making Skills.
• Gmp Procedures.
• Inspection Readiness.
• Organizational Skills.
• People Management And Leadership.
• Qa (Quality Assurance).
• Regulatory Compliance.
• Risk Management.
• Self Awareness.
• Technological Expertise.

Languages :

• English.