Specialist - Quality Operations

Overview

Specialist role in Quality Operations covering end-to-end supplier and vendor quality management activities.

What you'll do

• Draft and author the annual monitoring and certification report for incoming materials.
• Draft, negotiate (if applicable) and archive quality assurance agreements with suppliers and service providers.
• Evaluate and manage supplier change notifications (SCN) and initiate quality records for applicable SCNs.
• Draft and evaluate supplier incoming materials specifications.
• Perform quality risk assessments (QRA) for existing and new suppliers and service providers.
• Manage supplier and material qualification and supplier-related documentation.
• Prepare regulatory statements for materials and finished products.
• Manage quality records, support the Service Delivery team (SDT) with quality topics, and manage third-party participation in the TPRM (Third Party Risk Management) tool.
• Coordinate with stakeholders in the SIM (Supplier Information Management) approval process for quality deliverables.
• Prepare relevant contributing reports for the respective APQR section.
• Evaluate change control tasks and deviations related to supplier quality management.
• Coordinate the handling of discrepant materials and supplier complaints.
• Support audit preparation, QARP and FURP roles for audits, and CAPA management.
• Carry out functional representative activities.
• Deliver end-to-end supplier quality management activities as delegated by the business partner.

What you'll need

• Education: M Pharma, B Pharma, MSc or equivalent from a reputed university.
• Around 8 years of experience (listed as preferable experience).
• Language: English.

Nice to have

• 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).

Details

• Location: Hyderabad (Office).