Specialist - Quality Operations

Novartis is hiring a Specialist - Quality Operations in Hyderabad, India. Level rates it ; you can apply on Novartis.

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Job Description Summary

End to End Supplier / Vendor Quality Management Activities

Job Description

Supplier Quality Management:

• Drafting / Authoring of Annual Monitoring and Certification report for incoming materials.

• Drafting / Negotiation (if applicable) and Archival of Quality Assurance Agreement with

Suppliers/Service providers.

• Evaluation and Management of Supplier Change Notifications (SCN) and Initiation of quality

record for the applicable SCN.

• Drafting and Evaluation of Supplier’s incoming materials Specification.

• Performing Quality Risk Assessment (QRA) for existing and new Suppliers / Service providers.

• Management of Supplier/ Material qualification and supplier related documentation.

• Preparation of regulatory statement for materials and finished products.

• Management Quality records, Support the Service Delivery team (SDT) with quality topics and 3rdPAP Management in TPRM (Third Party Risk Management) tool.

• Co-ordination with stakeholders in SIM (Supplier Information Management) approval process for Quality deliverables.

• Preparation of relevant contributing report for respective APQR section.

• Evaluation of change control tasks/ deviations related to supplier quality management.

• Coordination in handling Discrepant Materials & Supplier Complaints.

• Audit preparation support, QARP and FURP Role for audit and CAPA Management.

• Responsible for the Functional representative activities.

• End to end deliverables for supplier quality management activities as per the delegated task from the business partner.

Preferable Experience - Around 8 Years

Education - M Pharma / B Pharma / MSc or Equivalent from Reputed university.

Languages: English.

Skills Desired

Collaboration, Communication, Data Integrity, Digital Fluency, Good Manufacturing Practices (GMP), Internal Quality Auditing, Managing Ambiguity, Operational Excellence, Problem Solving, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC)

How we rate this

Specialist - Quality Operations at Novartis rates 30 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.