Quality Specialist Tracelink
Location
Secunderabad | India
Job description
- Contribute to Business Requirements preparation and approval
- Review and approve validation protocols and reports
- Ensure conformity of validation documentation with evolution of applicable cGMP and applicable regulatory requirements
- Perform impact analysis and risk assessment link to Tracelink validation
- Support execution of serialization implementation at CMOs, including change management, testing, training, user access, lesson learned
- Ensure process improvements and changes are evaluated and implemented through the change control management process
- Maintain the traceability matrix
Quality system
- Ensure documented processes and procedures are in place for all activities to meet quality and compliance requirements
- Ensure continuous update of Tracelink validation documentation and SOPs
- Deliver training to the involved stakeholders of processes and procedures
Routine activity, events and CAPA
- Manage the Quality events (deviations, complaints, risks) and association CAPA related to the Tracelink serialization with CMOs in compliance with the External Manufacturing Europe procedures
- Management of incidents with the CMOs and Tracelink incident management
- Perform monitoring of errors and contribute to troubleshooting resolution
- Monitor CMO process performance and execute periodic KPI analysis
Audits
- Contribute to the internal audits
- Support the inspections (intellectual service)
- Manage CAPAs related to the observations from the audits
- Analyse of the impact of observations from the audits on Sanofi quality and serialization/aggregation processes
Continuous improvement
- Propose and implement process upgrades and efficiency improvements
Other
- Contribute to the masterdata file completion and review
- Act as Subject Matter Expert for Tracelink Serialization processes for Quality
- Participate to audits of Tracelink
- Contribute to any potential projects
Requirements:
- 5+ years of experience as Computerized System validation expert in pharmaceutical industry
- Expertise in GxP regulation, risk analysis, Quality management of Computerized systems related to pharmaceutical production and Supply Chain activities
- Knowledge of Pharmaceutical Serialization, pharmaceutical products packaging, aggregation, barcode printing and verification is a plus
- Fluent in English (written and spoken)
- Strong verbal and written communication
- Strong analytical and problem-solving skills
- Ability to work in a collaborative, cross-functional team
- Flexibility in handling assignments and tasks
- Work autonomously and execute complex activities and capacity to anticipate and report any alert with proposed solution/risk mitigation
- Service and results oriented
Job tags
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