Manage all operations and activities within the responsible service area of Artwork Operations to ensure PLS-TechOps delivery is in compliance with customer requirements, cGMP regulatory requirements and the Novartis Pharma Quality Manual & Policies.
Your responsibilities : Direct, oversee and coordinate all activities within responsible Artwork Operations services executed in support of product quality compliance and regulatory workflows like technical complaints, technical deviations, change control management, regulatory & printed packaging material compliance checks, regulatory submission & variation coordination, supplier qualification & management, product quality reviews and trends, performance reporting, artworks review and monitoring, audit support and application user support within PLS-
TechOps. Select, recruit, develop, manage, coach, coordinate and appraise the performance of direct reporting associates and ensure high quality performance management across the team.
Coordinate with Team Lead - Artwork Operations to ensure efficient and transparent allocation of resources to assignment of activities in support of service deliverables.
Author, review and approve GxP documents and reports like trends, performance, qualification, validation, quality events and technical investigations.
Generate and analyze predefined and ad-hoc reports in various applications (like AGILE PLM, AQWA etc.) and perform follow-
up actions if required. Support, monitors and reports on process, data and system integrity & performance, in order to proactively drive, together with Lead-
Artwork Operations, adherence to the defined process within the organization, as well as to achieve excellence in the process and system.
Lead new service or expansion projects, monitor and report progress and deviations, as appropriate. Work together with Team Lead -
Artwork Operations and customers to ensure they are kept regularly informed of issues related to the service delivery and elaborate risk mitigation plans, as appropriate.
Ensure all time readiness for customer and internal audits and follow up on implementation of agreed CAPAs in the responsible service area.
Collect and communicate the appropriate KPIs and metrics used to monitor team performance and project progress for management review and Customers.
Ensure the SOPs, working procedures, process maps, service dashboard, issue log, order management framework and time sheet is always kept updated for the responsible service area.
Provide technical guidance, mentoring and support to the onboarding associates in the team. Develop technical training content, establish training programs and impart training to the associates in the responsible service area.
Desirable requirements : Graduate / Post Graduate in Engineering / Pharmacy / Science or related fields Excellent written and verbal communication in English as a language.
Overall 10+ years of experience in Pharma Artwork, Labeling, Packaging or related field with minimum 2 years of hand on working experience in Artwork creation and change control.
Exposure to working in GxP environment is preferred.Why consider Novartis? 750 million. That’s how many lives our products touch.
And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment.
Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
Company / Legal Entity
Nov Hltcr Shared Services Ind