Specialist - Quality Operations

Specialist - Quality Operations

The Specialist - Quality Operations is expected to manager end to end supplier/vendor quality management activities.

Major Accountabilities:

• Drafting 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.
• Coordination 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.
• 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.

Obligatory Requirements:

• Education: M. Pharma / B Pharma / MSc or equivalent from reputed university.
• Experience: 8 years of pharmaceutical quality experience preferably in supplier quality management area.
• Basic project management skills.
• English fluent, written and spoken.

Skills Desired

Collaboration, communication skills, data integrity, dealing with ambiguity, digital savvy, leadership, operational excellence, problem solving skills, regulatory requirements knowledge.