CMC Compliance Specialist

Job Grade:  

Hiring Manager: Leon Espinosa Jorge 

Internal Posting Date:  - 

Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.

What the job looks like:

• Take over the ownership for the PCRs process and timely executing the relevant workflow steps as per internal procedure in alignment with the responsible GQPM/C (e.g. PCR impact assessment, actions plan definition and follow up, effectiveness verification, final implementation etc.);
• Continuously reviewing and improving PCR standard changes with related assessors, action items:
• Support the Site inspections/audits readiness by elaborating and preparing the official Product Change Control overview list according to request;
• Issue of regulatory CMC documentation timely and in due form by considering current and relevant guidelines to support obtainment and maintenance of national and international regulatory registrations; Preparation of responses to pharmaceutical questions from Authorities (e.g. deficiency letters, requests);
• Contribute to the CMC processes monitoring and continuous improvement by delivering the defined KPIs;
• Support the issuing and finalization of the Product Quality Reviews;
• Review of GMP documents to ensure compliance with national and international guidelines/regulations, MAs as well as internal procedures, including but not limited to validation protocols, stability protocols, analytical methods;
• Oversight and maintain the Global database for regulatory chemical-pharmaceutical quality documentation and maintenance/revision of related procedures;
• Execute any other ad hoc tasks that might be raised to support the company priorities achievements in accordance with instructions by.

What you bring to the table:

• At least 2 years of experience in Regulatory Compliance, Regulatory Affairs and/or Quality Assurance;
• Experience in GMP environment and QMS management;
• Grade as pharmacist or other natural science (e.g. chemist, biologist);
• Excellent team working;
• Global and service-oriented mind-set, strong sense of cultural/diverse backgrounds;
• Very good interpersonal, oral and written communication skills and abilities, positive attitude;
• Capable to identify the need for escalation in case of critical decisions/assessment to be made;
• Good time management and result-oriented;
• Accommodative and flexible way of working
  
  
   

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Leon Espinosa Jorge, the Hiring Manager