Title: Senior Quality Specialist
Department: Quality and Compliance
Location: India - Andhra Pradesh - Hyderabad
Employment Type: Full Time
Job Type: Regular
Company Profile:
PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
Description:
Senior Quality Specialist
Essential Function
Serve as a quality consultant to designated operational group(s). Activities include: identification of process improvement opportunities, process authoring and review, support for process re-engineering, providing GxP and process expertise to designated operational group(s), support for identification, management and prevention of project quality issues, providing audit and inspection support, and assist with the collection and reporting of project quality metrics as assigned.
Key Accountabilities
- Perform or assist the performing of quality assessments (e.g. quality gates, gap assessment, study file review), feeding back results to the operational teams, line manager and Head of the eClinical QM as appropriate.
- Assist the training groups to determine local training requirements (e.g. in quality processes, SOPs, software, etc.), and where needed support training delivery to ensure operational staff have appropriate training per the functional curricula to support their role.
- Working with the Process Optimization and Management (POM) group, ensure timely review and maintenance of Controlled Documents (e.g. SOPs and Work Instructions) in accordance with the defined timelines (e.g. every two years).
- Support the Validation Services Group (VSG) to ensure that all systems used by operational staff are validated in accordance with the Systems Life Cycle (SLC) and Computerized Validation Committee (CVC) Worldwide Standard Operating Procedures
- Provides support and advice to operational groups on the application of, and adherence to processes and the use of systems.
- Support eClinical QM and operations staff at audits, client assessments or regulatory inspections, as needed.
- Works closely with operations management and with line manager to ensure continuous process improvement.
- Keep abreast of systems and associated standards used within the technical areas that the individual supports.
- Develop project plans for assigned projects in line with Operations and eClinical QM strategies.
- Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
- Monitors and reports on audit responses, providing metrics as appropriate. Supports staff in use of automated quality systems. Confirms closeout of assessment findings, remediation of RRC audit and regulatory inspection findings in accordance with stated response times.
- Reviews the results of operational QC processes. Initiates escalation of significant quality events to the Head of eClinical QM and the responsible line manager.
- Regularly verifies the use and effectiveness of QC processes and quality gates and if relevant compile representative metrics.
- Using process mapping and analysis techniques identify areas for efficiency gains and process improvements within operations and quality groups, with subsequent development and implementation of action plans.
- Represents the relevant functional group(s), or supports the Head of eClinical QM in representing the functional group(s), in cross-functional forums and initiatives.
- Working with the Validation Services Group (VSG) assesses technology that may include the evaluation of appropriate systems/software to increase quality and productivity.
- Works closely with the Head of eClinical QM and Management within the relevant functional group(s) to ensure continuous process improvement
Skills
- Basic understanding of Computer System Validation and Systems Life Cycle.
- IT literate, Experience with Microsoft based applications and general knowledge of PC functions.
- Culturally aware and ability to think and work globally.
- Ability to travel as needed for the position and to support other offices.
- The ability to work as a team member or independently, with minimal supervision is necessary.
- The ability to gain trust and confidence with a variety of clients within PAREXEL.
- Excellent interpersonal, verbal and written communication skills
- Client focused approach to work
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Ability to effectively mentor less experienced members of staff.
Experience:
Education
- Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Language Skills
- Fluent in written and oral English
Experience
- Substantial clinical trials experience, with adequate experience in the technical services area (e.g. project configuration) or quality management area.
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