Support a program (plan, prepare and execute) of internal and external audits for QRA.
Ensure all identified actions / observations are appropriate to remediate the deficiency and are completed in a timely manner and complete reviews to ensure effectivity.
Work with the customer to undertake risk analysis of systems and processes, to propose process / functional audits.
Support regulatory inspections and customer audits as a functional QA subject matter expert.
Conduct trend analysis of audit and other quality related data, provide to internal / external stakeholders as agreed.
Assure completion of vendor qualification and surveillance activities performed and documented as defined in global and functional procedures.
Participates in the quality management system (QMS) improvements.
Provide guidance and ensure that ‘CAPA’s are correctly set up to capture risk assessment, effective corrective and preventive actions and have the required evidence.
Perform QA approvals of Quality Event records.
Keep up to date with latest guidelines from MHRA, FDA, EMEA and other Regulatory bodies.
Monitor legislation, implementing changes, and informing the company of any relevant changes.
Provide Quality Assurance support, guidance, and management of Quality Issues, as assigned.

Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 8 years of experience in pharmaceutical industry.)
6+ years of experience in the pharmaceutical industry
Previous Auditing experience required.
Experience interfacing with global regulatory agencies.
Ability to comprehend and communicate key regulatory requirements and expectations
Experience in collaboration, negotiation & conflict resolution skills
Knowledge of GPvP, cGMP, and GDP

Global Quality Assurance Auditor, Pharmacovigilance

Key skills