Quality Assurance Associate

Main Responsibilities:

• Support QA workflows in training assignments, QMS updates, deviation and CAPA tracking and follow‑up.
• Maintain accurate training records and monitor training completion within the Learning Management System (LMS).
• Assist in preparing documentation for audits and inspections, ensuring all records are complete, accurate, and audit‑ready.
• Perform quality checks on documents and data to ensure accuracy, compliance, and proper version control.
• Collaborate with PV Operations and other cross‑functional teams to gather information, resolve documentation needs, and support compliance activities.

Corrective and Preventive Action (CAPA) Management

• Issue deviations and CAPAs, and monitor notifications received from the QMS.
• Support deviation owners in identifying root causes, assessing impact on pharmacovigilance activities, and determining whether a CAPA is required.
• Track, classify, evaluate, and review deviations, deviation investigations, and CAPA plans.
• Report deviations to the appropriate deviation and/or CAPA owner as needed.
• Update the Deviation/CAPA Log and verify completion evidence prior to closure.
• Seek review and approval from the QA Team Lead or designee for deviation and CAPA documentation.
• Contribute to continuous improvement initiatives related to deviation and CAPA processes.

Audit and Inspection Support

• Assist in preparing documentation and logs for internal audits, external audits, and regulatory inspections.
• Retrieve training records, procedural documents, and other quality evidence as requested.
• Support the QA team in tracking and responding to auditor/inspector requests.

Team and Administrative Responsibilities

• Actively participate in QA meetings and contribute relevant updates or insights.
• Provide the QA Trackers and other required reports to the QA Team Lead or designee.
• Complete tasks assigned by the QA Team Lead in a timely and compliant manner.

General

• A total professional work experience of at least 3 years including 2 years experience in pharmacovigilance of which at least 1 year in pharmacovigilance Quality Assurance
• Fluent in English; Knowledge in additional language(s) is an advantage.
• Excellent verbal/written communication skills.
• Excellent organizational and prioritization skills.
• Ability to work in a fast-paced pharmaceutical environment needed.
• Ability to work collaboratively and effectively in a team environment.

Competencies

• Experience with computer applications including database management,
• Quality Management System, Good Documentation Practices, and Root Cause Investigation
• Basic understanding of GxP/GVP requirements and quality documentation practices preferred. Familiarity with quality systems (eQMS, LMS, DMS) is an advantage.
• Strong attention to detail, organizational skills, and willingness to learn.