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.
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.
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.
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.
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.
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.
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.
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.
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
Facilitate sponsor audits / regulatory inspections, as assigned
• Fosters a good working relationship with internal and external clients
Promote compliance within PAREXEL
Working knowledge and expertise of PAREXEL policies, procedures, and guidelines, as well as applicable national and international regulations and requirements; able to apply them as needed
• Proactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate
Working knowledge and expertise of PAREXEL policies, procedures, and guidelines, as well as applicable national and international regulations and requirements; able to apply them as needed
• Proactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate
Qualifications Education:
Bachelor’s degree in life science or equivalent experience gained by working in a relevant area (clinical research setting, laboratory, etc.)
• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Bachelor’s degree in life science or equivalent experience gained by working in a relevant area (clinical research setting, laboratory, etc.)
• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Knowledge and Experience:
Substantial experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including sound experience of applicable GxP auditing
• Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials
• Experience with using computer systems and software, including Microsoft Office
• Auditors must be detail oriented, able to maintain a ‘big picture’ / overview on the project / business
• Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically
Substantial experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including sound experience of applicable GxP auditing
• Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials
• Experience with using computer systems and software, including Microsoft Office
• Auditors must be detail oriented, able to maintain a ‘big picture’ / overview on the project / business
• Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically
Skills:
Ability to rapidly learn, understand and apply applicable PAREXEL and Sponsor procedures
• Ability to learn and use PAREXEL and client computer systems
• Client focused approach to work
• Ability to develop good working relationships with a culturally diverse group of PAREXEL and client personnel
• Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
• Excellent interpersonal, verbal, and written communication skills, including the ability to present at conferences, meetings and training sessions
• Ability to mentor / train auditors and others personnel
• Excellent organizational, analytical, problem solving and negotiation skills
• Effective at analyzing problems considering the ‘big picture’ and recommending appropriate corrective actions
• Ability to work independently and consistently in a fast-paced environment
• Accurate and detail oriented
• Excellent time management skills with the ability to prioritize workload and manage multiple and varied tasks / projects with enthusiasm
• A flexible attitude to work assignments and new learning and the ability to adjust to changing priorities and unforeseen events
• Ability to diplomatically address sensitive issues confidentially and professionally
• Ability to work professionally with highly confidential information
• Team leadership abilities and positive attitude
Ability to rapidly learn, understand and apply applicable PAREXEL and Sponsor procedures
• Ability to learn and use PAREXEL and client computer systems
• Client focused approach to work
• Ability to develop good working relationships with a culturally diverse group of PAREXEL and client personnel
• Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
• Excellent interpersonal, verbal, and written communication skills, including the ability to present at conferences, meetings and training sessions
• Ability to mentor / train auditors and others personnel
• Excellent organizational, analytical, problem solving and negotiation skills
• Effective at analyzing problems considering the ‘big picture’ and recommending appropriate corrective actions
• Ability to work independently and consistently in a fast-paced environment
• Accurate and detail oriented
• Excellent time management skills with the ability to prioritize workload and manage multiple and varied tasks / projects with enthusiasm
• A flexible attitude to work assignments and new learning and the ability to adjust to changing priorities and unforeseen events
• Ability to diplomatically address sensitive issues confidentially and professionally
• Ability to work professionally with highly confidential information
• Team leadership abilities and positive attitude
Additional Information:
Location: Hyderabad, Telangana
Education: B.Sc, B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Job ID : 50548BR
End Date: 20th March, 2019
Location: Hyderabad, Telangana
Education: B.Sc, B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Job ID : 50548BR
End Date: 20th March, 2019
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