By being hired into one of our Quality Management jobs at Parexel International, you’ll be a key member of the Parexel International team. Professionals in Quality careers come from a variety of backgrounds, bringing an assortment of knowledge and skills to every area of our business. A job in Quality at Parexel International may be waiting for you!
Post Name: Senior QA Auditor
Job ID: 62133BR
Work Location: Mohāli, Punjab
- 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
Accountability Supporting Activities:
- Perform as well as Report audits
- Independently plan, schedule, conduct and report a range of GxP audits in accordance with client requirements and also Sponsor procedures.
- Perform as well as deliver high-quality audits/ audit reports within defined 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 needed.
- Capability to review and, if necessary, identify improvements that improve the quality and also the clarity of audit reports
- Collect as well as review responses to audit observations as well as a follow-up/ escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of a satisfactory quality are obtained.
Lead audit programs
- Work with client QA as well as Operations to plan and manage a program of audits. Resolve program-related issues in a constructive as well as pro-active way.
- Ensure needed audits are performed and reported according to the client and QA requirements, on time and on budget.
- Review audit reports, responses as well as other programs deliverable to guarantee consistently high quality. Arrange meetings with client and also other key stakeholders as needed.
- Guarantee customer satisfaction as well as program profitability.
Support auditor training
- Help with the training of new/ less experienced auditors by performing co-audits, delivering training, and sharing knowledge as well as experience.
- Maintain records/ systems
- Maintain needed QA tools and also guarantee and QA systems are regularly updated with accurate info for audits as well as various other activities.
- Provide advice on regulatory compliance to clients, Operations and also Quality.
- Support the development, maintenance, review and improvement of procedures, systems and also tools by providing constructive ideas and suggestions.
- Provide input on QA planning and also strategy as requested.
Support the Sponsor Audit and also Inspection Team
- Help with sponsor audits/ regulatory inspections, as assigned
- Fosters an excellent working relationship with internal as well as external clients
- Promote compliance within – Working knowledge and expertise of policies, procedures, as well as guidelines, in addition to applicable nationwide and international regulations and requirements; able to apply them as needed
- Proactively recognize areas for a procedure/ procedural improvements, providing input to management and also taking the initiative, as appropriate
• Ability to rapidly learn, understand and apply applicable and Sponsor procedures
<!–Ads1-> • Ability to learn and use and client computer systems
• Client focused approach to work
• Ability to develop good working relationships with a culturally diverse group 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.