At STADA we pursue our purpose of “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values of Integrity, Entrepreneurship, Agility, and One STADA to achieve ambitious goals and shape the successful future of STADA.

STADA M&D SRL is an integral part of the STADA Arzneimittel AG group, one of the main pharmaceutical companies in Germany. 
STADA M&D SRL is located in Bucharest and Turda. It has a varied portfolio, offering patients both innovative and generic drugs, over-the-counter drugs, specialized pharmaceuticals (biosimilar), and CHC (Customer Health Care) products. 
For our team, we are currently looking for a QSC Specialist.

QSC Specialist   

Turda  | Romania (RO) | Full-time | Quality | All target groups 

Job purpose:

Verification of batch documentation and of all related quality activities required in the process of QP confirmation of bulk products and QP certification of finished products.

How will you help us:

• 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.

If you are looking for a new challenge and if you want to make a difference for people's health, we welcome you in our team! 
We are looking for candidates with entrepreneurial spirit, so please use our online job portal to submit your application: https://jobs.stada.com