Your responsibilities include, but not limited to:
Work closely with Head GQSI for strategic decisions. Serves as advisory for GQS QMS and compliance. Responsible to provide required guidance/support to GQS functions globally and not limited to local.
Design, implement and maintain QMS (quality management system) for the good manufacturing practice (GMP) services/ operations delivered by GQS. Ensure processes are in place and effective to identify gaps/ deficiencies in the established quality management system and which can independently trigger, investigate and implement the necessary corrective action in line with current external and internal standards to ensure continuous evolution of the quality system.
Establish and evolve effective and efficient governance structures for GMP Quality and Compliance activities, including establishment and reporting of KQI's. Strong collaboration required with peer GL and OPEX. Drive predictive compliance by effective application of Quality Risk management and Quality Plan execution. Ensure all time readiness of the activities for internal/ Business partner audits (including data integrity audits), host audits, and manage audit action plans for timely closure of agreed CAPAs.
Conduct/support Self-inspections as per the approved Self-inspection plan for GQS. Drive talent agenda: Lead people processes through recruitment, training, coaching and performance management. Engage and motivate the organization and deliver strong results with an empowered team. Drive the cultural development of GQS building on speak-up, trust, empowerment and accountability
Provide quality support to Nitrosamine risk based evaluation/ Changes, as required. Develop in collaboration with the partner functions, a culture of high awareness for Quality and Data Integrity . Represent GQSI in governance calls for Quality related topics .
Act as escalation contact point for stakeholders/partners and team members. For any issues (GxP or non-GxP) guide the team in resolving the same.
Support, monitor and report on process, data and system integrity & performance, drive adherence and compliance to the defined process within the organization, as well as to achieve excellence in the process and system. Lead related investigations to ensure compliance with local and global operating procedures.
Ensure everyday inspection readiness for self-inspection/Stakeholder audits/internal audits and follow up on implementation of agreed CAPAs in the responsible service area.
Drive innovation and entrepreneurial mind set to ensure team members are fully motivated, challenged, and engaged on delivering high quality work to achieve GQS and Sandoz objectives.
What you'll bring to the role:
Essential Requirements:
Critical Negotiations.
People Management experience of minimum 6 years
Experience in facing Audit
Project Management.
Collaborating across boundaries.
Operations Management and Execution.
Skills:
Audit Management.
Communication Skills.
Continuous Learning.
Dealing With Ambiguity.
Decision Making Skills.
Employee Performance Evaluations.
Gmp Procedures.
Inspection Readiness.
Organizational Skills.
People Management.
People Management and Leadership.
Product Release.
QA (Quality Assurance).
Self-Awareness.
Technological Expertise.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!
Join us!
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