Novartis Released Job Openings On 10/02/2022.Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide.Eligibility for the Quality Assurance Manager- ESOÂ as follows.
Vacancy Details:
Novartis Recruiting Bachelor or higher in Biochemistry, Chemistry or another related science with 10+ years of experience for Quality Assurance Manager- ESO Position.Complete Details for the Quality Assurance Manager- ESO as follows.
Important Details :
- Location : Hyderabad
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 10/02/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
- 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 maintain all associated quality systems e.g. maintain and update documents related to the supplier qualification and monitoring.
- Participate in 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 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 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 of 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 in-put 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.
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