Quality Operations Specialist

Specialist - Quality Operations

Job Description Summary

End to End Supplier/Vendor Quality management activities

Job Description

Major Accountabilities:

Supplier/Vendor Quality Management:

•        Drafting and 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.

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

•        Responsible for the Functional representative activities.

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

Preferable Experience & skills -

Around 8 Years

Basic Project Management skills

Fluent English

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

Languages:

• English.

Skills Desired

Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge

Experience Level

Entry Level