Job Description
Your Key Responsibilities:
Your Responsibilities Include, But Not Limited To
- Provide QA expertise and guidance to ensure compliance with requirement of the quality system are met, including implementation of quality risk-based and GxP-relevant process.
- Lead and manage a QA organization and/or quality project team and collaborate with business partners and other quality groups to ensure health authority and regulatory requirements are fully met. Translate functional QA strategy into applicable operational/compliance activities and support a risk-based implementation and execution of processes.
- Ensure quality and compliance gaps are addressed and executed for sustainability and implement strategic process improvement, including review of procedural updates, training, process improvement, effectiveness checks, etc.
- Monitor implementation of the Quality Plan and support inspection readiness activities, including participation in regulatory inspection preparation, management and follow-up.
- Support quality oversight/management of external service providers and IT systems supporting research and development activities and drive facilitation and follow-up of audits and inspections, and ensure development, implementation and completion of appropriate corrective and preventive measures for findings
- Ensure timely escalation of deviation/incidents and provide quality oversight for deviations/incidents, including robust investigations, root cause analysis and corrective actions implementation.
- Contribute towards lessons learned based on audits, inspections, incidents, regulatory intelligence, effectiveness checks on process implementations and metrics and support a culture of proactive, risk-based behavior
- Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt. Distribution of marketing samples (where applicable)
Essential Requirements
What you'll bring to the role:
- Minimum A bachelor's degree in life/ physical science such as chemistry, biology, microbiology, pharmacy, or biochemistry.
- Desired Postgraduate in Pharmacy or equivalent.
- Ability to read and comprehend documents, instructions, and correspondence in English.
- Ability to effectively present information in one-on-one and small group situations to project managers, suppliers, and other employees of the organization.
- 18+ years of experience People Leadership Operations Management and Execution Project Management
- Collaborating across boundaries Functional Breadth Critical Negotiations Industry/ Business
- Exposure English Regulations & Guidelines Health Authorities Vendor Management Risk
- Management Influencing and persuading Knowledge of TQM and related industry GxP
- standards and processes Quality Management
Skills
- Health Authorities.
- Pharmaceutical Development.
- Creativity and visioning.
- Analytical Development.
- Knowledge of GMP.
- Knowledge of CAPA.
- Regulations & Guidelines.
- Influencing and persuading.
- Six Sigma.
- Risk Management.
- Quality Management.
Why Sandoz
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art 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 and entrepreneurial spirit 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 encouraged!
The future is ours to shape!
Commitment To Diversity & Inclusion
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)
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