QA Specialist role at Novartis. Ensure GxP compliance in biopharma manufacturing, manage deviations & change control. GxP/QA exp in pharma manufacturing required. Apply now.
Guardian of Quality: Ensure Compliance in Life-Changing Medicine Production
At Novartis, we are reimagining medicine to improve and extend people’s lives. Our commitment to patients is underpinned by an unwavering dedication to quality, safety, and compliance in every step of our manufacturing process.
We are seeking a meticulous and proactive Quality Assurance Specialist to join our dynamic Quality Operations team. In this critical role, you will be the on-the-ground guardian of GxP compliance, ensuring that our biopharmaceutical and pharmaceutical manufacturing and distribution activities meet the highest standards of the Novartis Quality Manual, regulatory requirements, and local SOPs. Your vigilance and expertise will directly protect product quality and patient safety. If you are a detail-oriented professional passionate about quality systems and GxP, this is your opportunity to contribute to a world-leading pharmaceutical operation.
Your Mission: Ensure Every Batch Meets the Highest Standard
You will be responsible for the day-to-day QA activities that guarantee compliance and product quality. From batch record review to deviation management, your work ensures our manufacturing processes are robust, reliable, and inspection-ready.
Key Responsibilities
1. Batch Release & Documentation Oversight
- Review and approve batch documentation for accuracy, completeness, and GxP compliance prior to product release.
- Safely archive original batch records and critical quality documentation for the required retention period.
- Conduct GxP monitoring and self-inspections across manufacturing sections, following up on corrective actions.
2. Quality Systems Management
- Lead and manage critical quality processes: Investigate and approve deviations, complaints, and out-of-specification (OOS) results.
- Manage the Change Control process from initiation through to implementation and closure, ensuring robust assessment and documentation.
- Support internal and regulatory inspections as a subject matter expert for QA operations.
3. Continuous Improvement & Compliance Culture
- Analyze quality trends (deviations, CAPA effectiveness) to identify risks and drive continuous improvement initiatives.
- Develop, review, and update local SOPs to ensure they reflect current practices and regulatory expectations.
- Plan and deliver basic GxP training to operations staff to foster a strong, company-wide quality culture.
- Stay current on evolving GxP regulations and industry best practices, providing expert guidance to the site.
Who You Are: The Ideal Candidate
You are a quality-focused professional with a solid foundation in GxP regulations and hands-on experience in a pharmaceutical manufacturing environment. You are thorough, principled, and effective at managing complex processes and documentation.
Your Required Foundation:
- Bachelor’s degree in Pharmacy, Chemistry, Biology, Biotechnology, or a related life science field.
- Proven experience (typically 3-5 years) in a Quality Assurance role within pharmaceutical or biopharmaceutical manufacturing.
- Strong, practical knowledge of GxP regulations (GMP, GDP) and quality management systems.
- Hands-on experience with batch record review, deviation management, change control, and quality investigations.
- Excellent attention to detail, analytical skills, and a systematic approach to problem-solving.
- Strong written and verbal communication skills in English.
- Ability to work effectively in a team and collaborate across functions (Operations, QC, Supply Chain).
Skills That Drive Success:
- Change Control
- Quality Management & QA
- Risk Management
- Dealing with Ambiguity
- Continuous Learning
Why Build Your Quality Career at Novartis?
1. Impact on Patient Lives
- Your direct oversight ensures the safety and efficacy of medicines that reach patients worldwide.
- Be part of a global leader renowned for its commitment to quality and innovation.
2. Professional Growth & Development
- Gain deep expertise in QA operations within a world-class manufacturing network.
- Clear career pathways within Quality to Senior Specialist, QA Lead, or Management roles.
- Access to continuous learning and development in regulatory affairs and quality systems.
3. Collaborative & Purpose-Driven Culture
- Work in a supportive environment that values integrity, curiosity, and collaboration.
- Be part of a team dedicated to operational excellence and continuous improvement.
Ready to Uphold the Standards That Patients Trust?
If you are a quality professional dedicated to ensuring excellence in manufacturing and inspired by the Novartis mission to reimagine medicine, we encourage you to apply.
Join us in our commitment to delivering high-quality medicines every day.
Apply now to become a Novartis Quality Assurance Specialist.
