Senior Specialist-Quality Operations Job Vacancy @ Novartis

Senior Specialist-Quality Operations Job Vacancy @ Novartis

Novartis Pharma Specialist. Novartis.Career @ Novartis. Pharma job opportunity at Novartis.vacancy at Novartis. Interested candidates may apply online. Pharmaceutical Science job opening 2019 at Novartis. Check out all the details on Rasayanika.com

Job Title: Senior Specialist-Quality Operations

Job Id: 276239BR

Desirable requirements:

• Graduate in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology English Experience in chemical/pharmaceutical industry.
• Min. 2-10 yrs Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances or products or Medical Devices

Job Description:

• Author and contribute to the Novartis medical device’s Technical documents including but not limited to Design History Files (DHF), Post-Market Surveillance (PMS), Human Factors Engineering (HFE) documents.
• Review Device Master Record (DMR), identify the gaps using manufacturing expertise, provide recommendations in compliance with the applicable standards (ISO, FDA, MDD/MDR, etc.,)
• Prepare quarterly / annually post market surveillance (PMS) plan for medical devices
• Analyse the data in QlikSense and generate the reports in requested format.
• Analyse the risks arising from market complaints, clinical evaluation, development, operations and trend it.
• Analyse the feedback from external sources, risk management, APQR and Periodic safety update report for the product’s performance

and derive conclusion
• Initiate, manage and contributes to the Change Control process in Agile PLM.
• Support investigations/deviation processes and ensure follow-up of CAPA plans.
• Apply human factors / usability engineering to medical devices and recommend changes to improve the overall usability, ensure safe and reliable user experience
• Perform use error analysis, identify and recommend to eliminate the potential use errors.
• Author and contribute to Human factors engineering documentation (Task analysis, UFMEA, etc.,).
• Collaborate with multi-site teams and maintain high quality documentation in-order to enable exchange of information across the global teams.
• Open and track quality events in AQWA/Trackwise.
• Develop and maintain process SOPs, working procedures, process maps and service dashboard.
• Good to have knowledge in Usability tests, HFE methodologies, UX, Agile PLM, Trackwise, AQWA, etc.,
• Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining the position
• Maintain the work in inspection readiness level and provide the necessary support in any internal or external audit.
• Ensure that product-related data and information are maintained and kept up to date in the related database (e.g. Sharepoint, SubWay)
• Ensure timely completion and maintain the utmost quality in the deliverables..
• Services delivered on time (Timeliness)
• Error-free services (Accuracy)
• Services requiring management intervention to resolve (customer escalation)
• Customer satisfaction score, based on a regular customer satisfaction survey

Your responsibilities:
Use the GxP experience and the well-established knowledge of Quality Management System and the relevant International Legislation in 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-OSP organization.

Apply Online

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