Validation specialist at paraxel

Validation Specialist I\II\Senior\Validation Manager

DepartmentComplianceLocationHyderabad, Andhra Pradesh, India

Title: Validation Specialist I/II/Senior/Validation Manager


Department: Quality and Compliance


Location: India - Andhra Pradesh - Hyderabad


Employment Type: Full Time


Job Type: Regular


Req Number: pare-10023823

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:


JOB DESCRIPTION




Job Title Senior Validation Specialist


Department Validation Services Group (VSG) /


Technology Quality Management (TQM)


SBU G&A / PAREXEL Quality


Location Worldwide




Essential Function


Provide technical expertise, resource and support for the implementation, computer system validation (CSV) and ongoing maintenance activities related to systems used by PAREXEL in the provision of their services. Work to the appropriate corporate standards of quality and efficiency, SOPs/Guidelines, ICH-GCP and/or other international regulations as applicable. Be an ambassador for Quality within the wider organization. General responsibilities include; lead implementation projects for low and medium GxP risk systems; manage CSV activities; provide quality management support for technology related activities; represent PAREXEL systems in sponsor audits. 




Relationships


Reports To Manager (TQM), Senior Manager (TQM), Associate Director (TQM), Director (TQM)


Directly Supervises Not applicable


Provides Work Direction to Junior staff members and project teams


Works Closely with Clinical Logistics Services, Early Phase, Global Phase II-III, PACE, PCMS, Perceptive Informatics, Corporate IT, all PAREXEL Quality Units, All project team members


External Relationships Sponsors, Sponsor Audit teams, Vendors




Key Accountabilities


¿ SME for the roles of Designated Responsible Individual (DRI) and Validation Lead (VL)


¿ As DRI, be accountable for establishing & maintaining key validation deliverables on behalf of the Business Owner throughout the system lifecycle, including requirements gathering and user acceptance test planning for low and medium risk/complexity systems


¿ As DRI, be accountable for the continued maintenance of validated systems, including Change Control, for low and medium risk/complexity systems


¿ As DRI, be responsible for managing the input into Business process development for low and medium risk/complexity systems


¿ As DRI, be responsible for defining user / business requirements and align with relevant business processes for low and medium risk/complexity systems


¿ As Validation Lead, be accountable for the provision of validation consultation and advice to the computerized system validation (CSV) project team, including Risk Assessment(s) for medium and high risk/complexity systems


¿ As Validation Lead, be accountable for establishing key validation deliverables, including validation planning, summary reporting for medium and high risk/complexity systems


¿ As Audit Representative, represent technology quality measures and controls including CSV in sponsor audits


¿ Proactively support the RFI Lead, in the collation and answering of Request for Information (RFI) questionnaires and other appropriate sponsor requested information


¿ As CAPA Lead, be responsible for root cause analysis of technology quality related incidents (level 2 & 3) for single-project sponsors


¿ As risk mitigation lead, be accountable for risk identification and categorization, definition of relevant mitigations & follow through until remediation is complete for low and medium risk/complexity systems


¿ As a Change Control Board (CCB) member, be responsible for establishing, reviewing, authorizing and rejecting change requests from a technology quality & validation perspective for low and medium risk/complexity systems


¿ Proactively provide input and support and share responsibility for the creation, initiation and publication of VSG controlled documents (i.e. SOP(s), Manuals), in line with applicable PAREXEL standards and under the guidance of more senior staff


¿ Provide strategic input to the GxP regulatory experts, in providing information and/or position papers on current understanding of regulations for a particular technology related regulation or content area as directed


¿ Provides support to the Portfolio Validation Lead in overseeing and monitoring the compliance status and activities regards validation / maintaining the validated state for a particular business area or portfolio of systems


¿ Responsible for providing intermediate training to relevant PAREXEL personnel in VSG courses including System Life Cycle, Electronic Records & Signatures and GxP for Technology Environments


¿ Proactively updates and creates training material for VSG


¿ Support the VSG Supplier Auditor in conducting compliance audits and assessments of a supplier on behalf of Research Regulatory Compliance (RRC) or per specific business request. Lead offline Supplier Reviews (Self-assessment Questionnaires) as directed


¿ As an Internal Auditor, be responsible for conducting independent validation assessments in the form of compliance audits (single or multiple systems with medium GxP risk) or full audits (single or multiple systems with a low GxP risk)


¿ Adheres to the PAREXEL Quality structure and act as ambassador for quality within the organization


¿ Adheres to the Technology Quality structure and act as ambassador for technology quality roles and responsibilities


¿ Acts as a contact person for less experienced VSG members with the ultimate goal to share organizational, framework and administrative knowledge. This includes guidance on appropriate communication, organizational constraints and escalation


¿ Performs general obligations including time accounting, travel & expense submission, training, maintain personal records (CVs)


Skills


¿ Subject Matter Expert (SME) in both CSV and the pharmaceutical industry 


¿ Excellent interpersonal, verbal and written communication skills, decision making skills, business understanding, and strong organizational skills


¿ Personal qualities that include the ability to gain trust and confidence with a variety of clients within PAREXEL


¿ Ability to work in an action-oriented, fast-paced and rapidly changing environment


¿ Ability to prioritize workload and manage multiple and varied tasks with enthusiasm 


¿ Ability to make appropriate decisions in ambiguous situations


¿ Highly motivated and ability to work with minimal supervision


¿ Client-focused approach to work


¿ Exhibits a sense of urgency about solving problems and completing work


¿ Culturally aware and ability to think and work globally


¿ Ability to lead a 'virtual¿, global team as required


¿ Actively seeks opportunities to develop experience and knowledge


¿ Ability to travel as needed for the position and to support other offices


¿ Intermediate desktop software skills (MS Office, Excel, Visio, Adobe PDF etc.)




Education


¿ Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification, or 4+ years clinical research experience




Language Skills


¿ Excellent English written and oral communication skills

Experience:


Minimum Work Experience


¿ Clinical trials and / or research work experience a must, with emphasis on GCP and technology compliance


¿ Good understanding of technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems


¿ Testing and requirements gathering preferred.


¿ Basic Project Management experience preferred.