-Shristi Sharma, Team bioXone
Parexel QA Jobs – Life & Biological Sciences Apply Online. Life Science, Biological Sciences QA Jobs. Parexel Senior QA Auditor Life & Biological Science career. Parexel has job openings for life sciences & biological sciences candidates. Check out all of the details on the same below:
Parexel Vacancy Details
Designation: Senior QA Auditor
Requisition ID: 62133BR
Location: Mohāli, Punjab, India
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
- Follow-up audits
- 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 consultancy
- 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
Skills:
- Ability to rapidly learn, understand and apply applicably as well as Sponsor procedures
- Ability to learn and utilize and also client computer systems
- Client-focused approach to work
- Capability to develop good working relationships with a culturally diverse group and client personnel
- Willingness to work effectively with multiple supervisors in a matrix environment as well as to value the importance of teamwork
- Excellent interpersonal, verbal, and written communication skills, consisting of the ability to present at conferences, meetings as well as training sessions
- Capability to mentor/ train auditors as well as other personnel
- Excellent organizational, analytical, problem-solving and negotiation skills
- Effective at analyzing problems taking into consideration the ‘big picture’ and recommending appropriate corrective actions
- Capability to work independently and also consistently in a hectic environment
- Accurate and detail-oriented
- Outstanding time management skills with the capability to focus on workload and also manage multiple as well as varied tasks/ projects with enthusiasm
- A flexible attitude to work assignments and also new learning and also the ability to adjust to changing priorities and unforeseen events
- Capability to diplomatically deal with sensitive issues confidentially and also professionally
- Capability to work professionally with very confidential information
- Team leadership capabilities and also a positive attitude
Qualifications:
- Bachelor’s degree in life science or equivalent experience got by working in a pertinent area (clinical research setting, lab, etc.).
- Educated to degree level (technology, biological science, pharmacy or other health-related discipline preferred) or equal qualification or clinical research experience.
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