Senior Quality Assurance Associate

The QA Associate is responsible for supporting the Quality Assurance (QA) team in all aspects of the design, implementation and management of internal and external audits and corresponding Quality Risk Management activities.

The QA Associate will support the QA team to ensure internal/external audits are developed, managed, maintained, and delivered in line with PrimeVigilance procedures.

The QA Associate will conduct all activities described, including but not limited to:

• Hosts/supports audits (routine, due diligence, qualification) and inspections of Primevigilance performed by clients/third parties and regulatory authorities as agreed with Quality Audits Manager and/or Director, Quality.
• Supports PrimeVigilance functional teams pre-, during and post-audit by clients or by internal QA function
• Assists in client specific requests for audit scheduling
• Assists in maintenance of trackers involved for audit related tasks and the maintenance of the SharePoint
• Supports the oversight, maintenance, scheduling of audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities.

CAPA Support Activities

• Supports in tracking of the vendor audit CAPAs.
• Support in the facilitation and review of vendor CAPA responses
• Input into the global audit CAPA tracker

Internal Audits

• Ensures documents and trackers from internal system and/or vendor audits initiated by Primevigilance, are kept up to date.
• Assists in the development and maintenance of the internal risk assessments.
• Conducts other ad-hoc activities as requested by Quality Audits Manager and/or Director, Quality.

Specified Additional Responsibilities

• The QA Associate will also support the Global Quality Function as needed.
• Other QA support as needed

Requirements

University degree in a scientific discipline, or equivalent industry experience

Essential

• Previous experience in the pharmaceutical and/or regulated industry in a quality setting – preferably in Pharmaceuticals or Healthcare
• Understanding of the principles of Quality Assurance
• Excellent communication and facilitation skills within a global organization
• Excellent approach to workload management and ability to deliver results in tight timelines
• Flexible approach to work and positive response to process change where necessary
• Good attention to detail
• Proactive and self-motivated
• Good organization skills and ability to multitask