Specialist-Quality Operations Job Opening 2019 @ Novartis

Specialist-Quality Operations Job Opening 2019 @ Novartis

Specialist-Quality Operations Job. Pharmaceutical & Chemical Science Jobs. Applications are invited for the post of Quality Officer @ Novartis.Career @ Novartis. Pharma job opportunity at Novartis.vacancy at Novartis. Interested candidates may apply online. Check out all the details on Rasayanika.com

Job ID: 268476BR

Position Title: Specialist-Quality Operations

No.of posts: 01

Eligibility: Graduate in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology English Experience in the chemical/pharmaceutical industry.

Experience: Min. 2-10 yrs Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances or products or Medical Devices.

Job Description:

Use the GxP experience and the well-established knowledge of Quality Management System and the relevant International Legislation in the daily role. Contribute to the operational business in compliance with cGMP regulatory requirements and the Novartis Pharma Quality Manual and Policies.Support PLS delivery by implementing processes, systems and tools that realize the Quality Operations services across Novartis divisions.
Support the successful implementation of the NBS vision and strategy and the Novartis Quality strategy within PLS-M&SO organization.

Responsibilities:

Post Market Surveillance:

•Assessing the quality, performance, efficacy and safety of a medical device once it is placed on the market.

•Perform proactive analysis for warnings of potential quality

issues, benchmark results with competitor devices, or field-based inputs to risk control measures defined in the device Risk Management File (RMF).

•Design and Issuing the Quarterly / Annually Post market surveillance (PMS) Plan for Medical devices.

•Designing the QlikSense Enterprise environment for data analysis and KPI reporting

•Expertize in navigating across SubWay, trackwise/AQWA and Agile PLM. •Opening and tracking Quality Events in AQWA/Trackwise.

•Experience in Writing technical documentation related to medical devices. •Designing and maintaining data visualization tools like QlikSense.

•Preparation of device Risk Management File (RMF) and Ensure Product Quality Risk Assessment (i.e. HLPA).

•Interacting with data contributors across the organization, in order to get data from e.g. ARGUS, AQWA, APQR, PSUR…

•Collecting and thoroughly analyzing data from proactive sources as defined in the PMS plan (e.g. by conducting literature research, browsing health authorities databases). •Conducting first-level analysis, interacting with the cross-functional team members to ensure thorough data analysis.

•Follow-up with the action item, building the annual review slide deck with first-level charts, sharing with management.

•Preparing external communication format, in order to share PMS summary and conclusions outside of Novartis, as appropriate (e.g. to the legal manufacturer of a medical device used by Novartis in a system).

•Preparation and maintenance of the Post Market Surveillance documents in the repository for audit readiness.

•Prepare or update Design history files and risk assessment documents..

•Collects and analyses data eventually including statistical analysis.

•Develop and maintain process SOPs, working procedures, process maps and service dashboard.

•Analyze the risks arising from the market complaints, clinical evaluation, development, operations and trend it.

•Analyze the feedback from external sources, risk management, APQR and Periodic review. safety update report for the product’s performance and derive conclusion.

•Support maintenance of the knowledge and the history of the product(s) process throughout the entire commercial lifecycle.

•Initiate, manage and contributes to the Change Control process. support investigations/deviation processes.

Apply Online

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