Quality Operations Specialist QP Support

• Has knowledge and ensures the compliance with GMP rules, other internal and external guidance in place, Marketing Authorization, Manufacturing license, other regulatory requirements to be able to evaluate the compliance of batch documentation
• Preparation of batch documentation for bulk batches and finished product batches, evaluation of missing documents
• Batch documentation (manufacturing/packaging records, testing documents, etc.) – reviews and verify the compliance with marketing authorization and current manufacturing license, other applicable regulations
• Prepares the required documentation needed by Qualified Person (checklist and confirmation statement / certificate of conformity)
• Review and verify in the quality electronic system the quality issues, change controls, other action items which can have impact on the batch confirmation / certification
• Verification of batch quantity, serialization report
• Ensures all the logistic activities related to bulk and finished product batches (downloading the documentation, scanning, archiving)
• Involvement in closure process of the investigation related to quality issues and market complaints, support to Qualified Person
• Involvement in the recall process management as support to Qualified Person
• Subject matter expert for production processes (manufacturing/ packaging/ validation)
• Close collaboration with Production planning and Supply Chain (deliveries) to fulfill the plan for batch verification
• Daily monitoring of the activity; escalation to Qualified Person of all issues identified
• Daily participation to Tier 1 and Tier 2 meetings
• Preparation of the information for weekly and monthly KPIs reports
• Preparation of SOPs for its specific activity
• Identifies the needs for continuous process improvement

The skills you need:

Education: Degree in pharmacy, chemistry, biology;

Languages: Local language; English fluent in speaking and writing;

Experience: Preferably with minimum 3-5 years experience in the Pharmaceutical Industry and GMP environment ;

Digital skills: Knowledges of SAP, LIMS, MES are desirable.