Risk_Risk Transformation_Regulatory Compliance

Job description

 Position:  Life Sciences Q&C - Staff

 

Job Description 

As a Life Sciences Quality & Compliance (Q&C) Staff, you’ll actively establish, maintain and strengthen internal and external relationships. With the guidance of Seniors, Managers, Directors and Partners, you’ll execute critical projects for Life Sciences clients. You will actively contribute to improving operational efficiency on projects and internal initiatives. Inline with our commitment to quality, you’ll consistently drive projects to completion and confirm thatwork is of high quality. When working on engagements, you’ll report to higher levels of management,who will expect you to anticipate and identify risks, and raise any issues with them as appropriate. You will be responsible for overall client service quality delivery in accordance with EY qualityguidelines & methodologies. Establishing, strengthening and nurturing relationships with clients(functional heads & key influencers) and internally across service lines and proactively will also bea part of your day-to-day activities. You will assist in developing new methodologies and internalinitiatives and help in creating a positive learning culture. In line with EY’s commitment to quality,you’ll confirm that work is of the highest quality as per EY’s quality standards, by reviewing the workprovided by junior member.  

 

Client responsibilities

·   Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach 
·  Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. 
·  Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. 
·  Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach 
·  Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Assist Seniors, Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. 
·  Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. 
·  Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines 
·  Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. 
·  Actively contribute to improving operational efficiency on projects & internal initiatives. 
·  Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.

People responsibilities

·  Foster teamwork and a positive learning culture 
·  Understand and follow workplace policies and procedures 
·  Participate in the organization-wide people initiatives 
·  Get cross skilled and cross trained as per the business requirements 

Requirements (including experience, skills and additional qualifications)


Technical skills requirements

·  Quality & Compliance managed services and advisory experience in of Life Sciences Domain. 
·  Domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance 
·  Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems 
·  Hands on experience on authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. 
·  Basic knowledge of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, 
·  Basic knowledge of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. 
·  Versed with ICH guidelines, ISPE framework on Risk management, System Development Life Cycle concepts. 
·  Basic Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization. 
·  Versed with SOP documentation, analyzing the work instructions, user manuals 
·  Hands on experience of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. as they relate to Computer Systems 
·  Basic understanding of Data Integrity requirements 
·  Basic Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.  
·  Experience in supporting Audits / Inspections would be add-on

 

Experience/ Education    
·  B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Post graduate in Science (Preferably in Chemistry/Bio-Chemistry) with 3-5 years of experience with Big 4 or Multi-National Life Sciences companies 
·  Good interpersonal skills; Good written and presentational skills 
Certifications (desirable) 

·  Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
·  Information Security or Risk Management certifications would be add-ons.