Quality Assurance Manager

Role & responsibilities

Leads and optimizes QA function that supports organizations QMS in compliance with

respective international regulatory requirements.

• Hosting and support in external/client audits and regulatory inspections hosted by Auriga.

• Audits and inspection handling.

• Conduct internal system and process audits within Auriga systems.

• Conduct external audits including the audit of vendors, clients and/or clients business

partners and service providers.

• Lead and manage a team of clinical audit professionals, providing guidance, training, and

mentorship.

• Support the operations team for adequate root cause identification, conducting gap analysis

and implementation of corrective action plan.

• Participate in risk assessments and preparation of risk-based audit plan for auditing internal

processes, vendors and customers. 

• Supporting the CAPA management in audit and Inspection related CAPAs.

• Support the document life cycle management, deviation handling process and change control

process.

• Prepare audit reports to communicate outcomes of quality review activities.

• Preparation and or/review of company standard operating procedures (SOPs) and such other

quality documents.

• Interpret and implement quality assurance standards within the organization.

• Liaise with quality representatives, internal customers and external customers across Auriga

global access offices as required to achieve quality objectives.

• Ensure development and maintenance of a PV Quality System for Standard Operating

Procedures, auditing, review CAPAs, Change control and deviations.

• Evaluate client audit and regulatory inspection findings and prepare and distributes reports to

observation staff, management and customers.