At Novartis, we aim to change the practice of medicine, and innovation not only means developing effective, targeted medicines quickly, but also ensuring that these medicines get to the patients who need them. Our vision is to be a trusted leader in changing the practice of medicine. To achieve that, we are continuously seeking talented individuals who are passionate about making a difference in healthcare to be a part our team!
We are currently seeking an experienced GMP Officer (Senior QA Engineer/Specialist) for our San Carlos, CA site.
The GMP Officer is an essential role within the Quality Assurance Department to provide compliance support and oversight on the shop floor. This role is responsible for identifying and resolving compliance issues within the Process Unit (manufacturing) unilaterally and cross-functionally with operational oversight on internal audits, deviation management, proactive process improvement initiatives, and assistance with Regulatory Agency inspections/activities, as needed.
• Responsible for ensuring compliance with Federal (FDA, EPA, OSHA), State and local regulations, adherence to all company policies and procedures relating to current Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), Health, Safety and Environmental Protection.
• Responsible for commercial product, raw materials and components release, disposition and material handling.
• Provide oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.
• Perform random verifications of routine operational requirements, both on a product/batch level as well as on a process level.
• Responsible for driving product quality improvements by coordinating investigations and corrective actions with all operating units, QA, Site Services, and suppliers to determine root causes and corrective actions to resolve complex, compliance related issues such as product failures, stability failures, and compliance issues, including supplier investigations and complaints.
• Analyze and make decision on deviations reports in AQWA (TrackWise) compliant with cGMP guidelines and SOPs, while escalating the decision for critical /major deviations to QA management.
• Drive timely resolution of deviations, disposition of batches and escalates in case of delays within the Process Unit.
• Support Quality Assurance and Compliance with internal audit coordination, response, and follow-up activities.
• Evaluate current operational practices and recommend process improvements to ensure continued compliance to regulatory requirements and industry expectations.
• Actively participate in process improvement teams, initiatives, and/or projects and take a leadership role in guiding major programs.
• Participate in or lead internal/external audits, as needed.
• Compile data and information for contribution to Risk Assessments and Reports (e.g. APR/PQRs) and may actively author risk assessment, and reports.
• Author and revise SOPs as appropriate.
• Participate in and conduct trainings related to Quality Assurance.
• May act as point of contact and backup for other GMP Officers in the group.
• Ensure compliance with GMP/HSE regulations, Novartis policies, procedures and standards as appropriate for the role and act as a champion for Quality Culture ensuring a safe working environment.
• Bachelor degree in a scientific discipline. Equivalent experience may be accepted.
• A minimum of 10 years of related pharmaceutical experience.
• Excellent problem solving skills demonstrating ingenuity and creativity.
• Experience in Deviation Management and batch disposition.
• Auditing and technical report writing experience.
• Expert knowledge and understanding of GMPs, keeping up to date with current industry issues and changing regulations.
• Excellent oral and written communication skills.
• Strong proficiency with Word and Excel.
• Demonstrate leadership ability and excellent interpersonal skills.
• Able to work independently and effectively as a member of a cross-functional team.
• SAP and TrackWise knowledge a plus.
Please apply www.novartis.com.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.