Novartis India Ltd. has announced a job opening for the position of Quality Assurance Manager at the Mumbai location.
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 1 billion people globally and we are finding innovative ways to expand access to our latest treatments. About 125,000 people of more than 140 nationalities work at Novartis around the world.
Position Title: Quality Assurance Manager
Department: Quality Assurance
Qualification: Bachelor or higher in Biochemistry, Chemistry or other related science
- Proven experience of 10+ years in the pharmaceutical industry, with direct experience with APIs.
- Experience in QA Operations, production, QC, and/or other relevant operational areas, but must include minimally 5 years in QA, and 3 years of management and or project management experience.
Work Location: Mumbai
- Detailed knowledge of cGMP requirements.
- Strong understanding of regulatory requirements for commercial products.
- Proven track record with FDA, EMEA, and other Health Authorities.
- Strong understanding of risk assessment and risk management fundamentals/tools. Technical understanding of pharmaceutical/ biological processes.
Approve and maintain quality oversight with respect to the supply of materials to Novartis, from global external suppliers of chemicals (strategic raw materials, Intermediates, and Drug Substances) by working in Supply Relationship Teams. These materials are being supplied to >75 Novartis Technical Operation sites.
To ensure appropriate quality oversight, assessment, and mitigation of quality risks, that may potentially negatively impact the supply of purchased strategic ESO chemicals (regulatory starting materials, Intermediates, and API’s), and to ensure that all aspects of the relationship and management thereof, are in compliance with cGMP’s, regulatory requirements, the Novartis Quality Manual and Pharma industry practices.
YOUR KEY RESPONSIBILITIES:
- Your responsibilities include, but not limited to:
- Responsible for ensuring quality oversight for purchased API’s and strategically important regulatory starting materials and chemical intermediates supplied into Novartis NTO sites worldwide.
- Participates in and approves changes of supplier qualification and certification status for all external Suppliers, and maintains all associated quality systems e.g. maintain and update documents related to the supplier qualification and monitoring.
- Participate in the escalation of all potential quality issues as per the Novartis escalation policy to higher-level management, especially to the QA Lead and ESO Global QA Head Chemicals & Anti-infectives, and initiating all actions as required. (483’s, Warning Letters, FDA Field Alert Reports, Notifications to the Drug Shortage Office, etc).
- Manage major and critical quality issues (Complaints, deviations, recalls, counterfeits, product tampering, stability failures, and any regulatory non-compliance identified, as applicable) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are accurately executed and all appropriate Corrective and Preventative actions are put in place in a timely manner.
- Perform risk assessments in case of specific quality events at a supplier, including collecting relevant data from NTO sites and other stakeholders, and approval of site-specific risk assessments where required. Evaluates risks for product quality and patient safety and proposes market actions
- Participates in High-Risk Supplier evaluation process, and assures that actions originating from this process are executed and documented. Proactively communicates supplier status changes (incl. high-risk suppliers) with NTO sites.
- Provide direction and support to third parties and ensure that they are qualified, achieve a high level of competence, and are motivated to carry out their duties to ensure that the materials produced to meet the Novartis quality, efficacy, and safety requirements.
- Travel to external suppliers manufacturing sites during audits, continuous improvement activities or to resolve any issues. Responsible for preparing Quality Agreements and Quality Risk assessments for all External Suppliers within the responsibility of the team, and for maintaining documentation in relevant IT systems.
- Support remediation of any gaps identified in Quality Systems and ensure any issues are addressed. Provide the quality presence and input to Technical Meetings with the external suppliers and establish good working relationships with clear communication and defined actions and goals.
- Request, review, and process GMP documentation as defined by the Quality Agreement and Novartis SOPs. Manage the Quality Aspects of the relationship in accordance with the effective Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.
- Responsible for coordinating and ensuring that quality Auditing of external suppliers is carried out according to the Novartis Quality Manual – maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs (QARP, FURP). Maintain and update documents related to the audits in the relevant systems.
- Ensure that Change requests, either from the External Supplier or from Novartis, are raised in the Novartis Change Control system, and where applicable, are managed according to the Quality Agreement and Novartis SOPs from receipt, through to the implementation and closure.
- Ensure that coordinated contact is maintained with other Functions within Novartis also dealing with External suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations (GOO), etc.
- Support site readiness for regulatory inspections at External suppliers where appropriate, and support site remediation from inspections where required.
- Ensure that support is provided to NTO sites in their preparation for Novartis or Health Authority general GMP inspections and PAI inspections.
- Performing technical visits of suppliers, issue technical visit reports, and perform follow-up.
- Act as a person in the plant (PIP) when necessary in some specific suppliers to ensure on-site supervision of critical activities and to provide formal reports to Novartis regarding activities performed.
INSIDE THE ORGANISATION
- Implement and maintain local Quality Systems and Standard Operating Procedures defining all the processes for managing External suppliers.
- Ensure that the ESO QA Lead, Global QA Head, and the Supplier Relationship Manager is kept informed of all critical and major issues which may have an adverse effect on the quality of the product at an External Supplier.
- Together with the Supplier Relationship Manager provide direction, formulate strategies and make decisions that ensure the efficient operation of the External Supplier business as a whole.
- Participate in the Business review of External suppliers. Participate in the Reporting on QA External Supplier activities – this is to include Risk Assessment, reporting, and managing of defined KPI’s
- Ensure that coordinated contact is maintained with other functions within Novartis also dealing with External suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc.
- Support execution of the ESO Quality Plan. Participate in projects as defined and ensure that all aspects are implemented and followed up. Support the team in achieving targets defined in ESO Q-plan.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends.