Work as Senior Quality Assurance Auditor at PAREXEL | B.Sc, B.Pharm

 

 

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.

Post : Senior Quality Assurance Auditor

Job Purpose:
The Senior Auditor will have an in-depth understanding and knowledge of appropriate GxP compliance and other applicable regulations and laws, PAREXEL procedures and appropriate PAREXEL processes, which allows the individual to plan and conduct internal and external audits independently and to be able to mentor less experienced auditors. In liaison with QA Management and staff, provide direction and coordination for project activities related to assigned areas. Provide advice on regulatory compliance.

Specialized Area:
Billable Audits & Client Relationships:
• Act as QA Lead on audits program(s) as assigned by Line Management
• Ensure audits programs are managed to a high degree of client satisfaction
• Ensure required audits are delivered in accordance with clients requirements and PAREXEL/Sponsor procedures as applicable
• Ensure that systematic issues raised during billable audits are escalated and addressed
• Maintain relationships with clients
• Support client QA needs and identify areas where billable services may be offered
• Develop and optimize new and existing processes to maintain and improve quality within the billable group.

Perform and Report audits:
Independently plan, schedule, conduct and report a range of GxP audits in accordance with client requirements and PAREXEL/Sponsor procedures.
• Perform and deliver high quality audits /audit reports within specified timelines / budgets, with limited oversight. Lead or participate in co-audits / observed audits with client representatives or other QA auditors. Travel internationally for audits as required.
• Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports.

Follow-up audits
Collect and review responses to audit observations and follow-up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained.

Lead audit programs
Work with client QA and PAREXEL Operations to plan and manage a program of audits. Resolve program related issues in a constructive and pro-active way. Ensure required audits are performed and reported in accordance with the client and PAREXEL QA requirements, on time and on budget. Review audit reports, responses and other program deliverable to ensure consistent high quality. Arrange meetings with client and other key stakeholders as required. Ensure customer satisfaction and program profitability.

Support auditor training
Assist with the training of new / less experienced auditors by performing co-audits, delivering training, and sharing knowledge and experience.

Maintain records / systems
Maintain required QA tools and ensure PAREXEL and QA systems are regularly updated with accurate information for audits and other activities.

Provide consultancy
Provide advice on regulatory compliance to clients, PAREXEL Operations and PAREXEL Quality. Support the development, maintenance, review and improvement of PAREXEL procedures, systems and tools by providing constructive ideas and suggestions. Provide input on QA planning and strategy as requested.

Support the Sponsor Audit and Inspection Team
Facilitate sponsor audits / regulatory inspections, as assigned
• Fosters a good working relationship with internal and external clients

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