APPS Specialist

Job Description Summary

Supports the follow up of local and regional processes, procedures and activities related to data management in ERP system and data analysis such as trending, required for drug product control, preserving compliance of local, regional and global quality standards as delegated by the Novartis entities.

 

Job Description

Major accountabilities:

• Support users in applicable systems as superuser (such as SAP). 
• Responsible for the data management in ERP systems such as SAP in quality modules such as (but not limited to) create/ update of inspection plans as current analytical monography, create/ update certificate profile as required. 
• Review and troubleshoot issues during uploading or updating specs or creation of manual inspection lots. 
• Responsible of data recollection and authoring of Quality reports for data analysis to identify opportunities at country or site level.
• Guarantee region DI and GxP compliance according to current health authorities’ regulations and applicable guidelines as well as corporate standards. 
• Prepare, update, and review standardized operating procedures and work instructions, guaranteeing reproducible processes that fulfil regional and global regulations health authorities and corporate normativity. 
• Assist and support internal and external audits. Establish and verify timely execution of all CAPAs derived from these audits. Collaborate in appropriate resolution of all deficiencies detected during health, internal, corporate and security authorities’ audits. 
• Propose, lead and/or actively participate in initiatives and projects to improve Quality Assurance at a local, regional and/or global level. 
• Participate in the strategy and actions for regional projects of Quality Assurance Digital Solutions, in order to create a more productive and efficient environment in QC laboratories, in accordance with Novarits' general Digital QC strategy. 
• Analyse, evaluate, identify, and propose solutions directed to mitigate data integrity risks throughout analytical technology use. 
• Collaborate in analytical processes harmonization, fulfilling global standards and procedures. 
• Set and provide input on priorities for owned activities. 
• Demonstrate customer-oriented service mindset in handling and executing deliverables. 
• Responsible for data compilation and preparation of dashboard/data bases on regular basis to track and report deliverables. 
• Regularly communicate with partners to collect feedback on supported processes.  
• Report and record Issues, Deviations, Quality Events emerging from process delivered, and communicate progress as appropriate in collaboration with team leader. 
• Ensure efficient, timely and clear communication to all involved partners (local and global functions) as required for follow-up on activities under scope.  
• Build and maintain high expertise and continuously acquire process knowledge. 
• Support and participate in the implementation and modification of processes. 

Key performance indicators:

• Processes under scope KPIs and KQIs.
• High customer satisfaction/responsiveness (no customer complaints).
• Adherence to projects timelines and proactive management of upcoming issues.
• Generation / delivery of reports related to owned activities.
• No issues due to non-observance of cGMP, SOPs and no critical deviations/findings.

Minimum Requirements:
Work Experience:

• Bachelor's degree in a related career in pharmaceutical, chemical or biological area, with a professional license.
• At least 3 year in the Pharmaceutical Industry, experience in key areas such as Quality Assurance, Quality Control, Stability or Analytical Services.

Skills:

• Continuous Learning.
• Dealing With Ambiguity.
• GMP Procedures.
• QA (Quality Assurance).
• Quality Control (Qc) Testing.
• Quality Standards.
• Self Awareness.
• Technological Expertise.
• Technological Intelligence.

Languages :

• English.

 

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence