Senior Compliance Associate

Overall Job Objectives 

• This role is in the Compliance Team within the Pharmaceutical Affairs Department (which consists of Compliance, Quality and Regulatory teams) at Aspen Global Incorporated (AGI).
• This resource person will report to the Compliance Leadership and will be managing Medium/High complexity processes independently as well as supporting on the development of overall compliance team to maintain and improve the Quality Management System (QMS) in AGI. The position demands flexibility accountability and ownership along with respect to driving initiatives and assigned responsibilities.

Duties & Tasks 

• Identify and Drive initiatives to enhance the overall Quality Management System in AGI office, establishing process in compliance with the GxP requirements and training other departments.

• Main responsible of Medium High Complexity Quality Process:
•    Analyze the data in order to identify trends, risks and opportunities for improvement.
•  Take ownership and complete high impact activities related to the process.
• Delegate the low complexity activities to Junior and Compliance Associate.
• Keep the procedure updated according to the applicable compliance GxP standard.
• Provide training to applicable AGI staff when required and ensure that the process is followed.
• Provide guidance and support to end users of the process.

• Manage vendors on quality related activities:
• Liaise with Vendor for all quality/compliance related activities;
• Develop and enhance ways of working and processes with Vendors;
• Coordinate communication between different stakeholders impacting the vendor;
• Monitor the required qualification status and ensure the relevant documentation is up to date and archived in the correct repository.
• Coordinate the completion of costumer complaints, deviation and change controls with the impacted stakeholders.
• Negotiation of technical agreements with the impacted stakeholders.
• Ensure the compliance of the products/services supplied by the vendor by following the applicable internal procedures.

• Coach Junior and Associates:
• Guide Junior and Compliance Associates on daily activities to be performed by them and ensure its completion in a timely manner.
• Provide technical sessions to uplift their technical capabilities
• Provide feedback to support on the development of soft skills applicable to their job description.
• Support the direct manager to perform their performance review.

• Technical:
  • More than 5 years’ experience in GxP in Pharma is essential.
  • Intermediate to Advance Microsoft Office proficiency (Excel, Word and Power Point).
  • Problem Solving and Project Management skills

     

• Soft skills:
• Collaboration with team members.
• Good Communication – verbal, written, presentation.
• Time Management and prioritization.
• Coaching skills