ET&P_ AS - CSV - AM

The Team

Deloitte helps organizations anticipate and adapt to changes in the regulatory environment, and build better programs and controls to address the wide variety of regulations and regulatory risks. We work with clients and regulators on effective remediation in response to compliance events.
Work youll do
As a part of our Risk Advisory team youll build and nurture positive working relationships with teams and clients with the intention to exceed client expectations.
Youll:

Managing the CSV projects related to reviews, assessments, and implementation
IT quality systems framework design and implementation
Q&C services for global consumer health care, medical devices, and pharmaceutical companies
CSV compliance of GxP processes for pharmaceutical companies
GxP Business process review
Development of integrated GxP and IT compliance
Standard operating procedures and guidelines
GxP and IT compliance assessment
Define the Validation strategy of IT Software and Systems
Actively participate in the Validation Life Cycle of regulated IT projects or platforms by planning validation deliverables, working on validation documentation, participating in authoring deliverables, functional requirements definition, traceability matrix, validation protocol development,
Validation testing and deviation management; and working closely with cross-functional project teams.
Ensure 21 CFR Part 11 compliance for Computerized system
Provide User training on CSV and increase awareness about compliance
Responsible for reducing Gaps identified in various GAP/Risk Assessments existing and new computerized systems and providing a remedial action plan for compliance.
Carrying out an Audit of IT systems to ensure regulatory compliance
Manage the specified business/systems requirements, working closely with the designated Project Manager to facilitate the progress of the project Coach/mentor staff and provide technical leadership, as needed



The key skills required are as follows:

IT Quality, Regulatory, Compliance (IT-QRC)
Quality guidelines mentioned by FDA, MHRA, and other regulatory bodies
GxP practices and GAMP5 guidelines.
Computer System Validation of various COTS products like COGNOS, IMPACT, BAELN and other related applications used in pharmaceutical industries
Experience in activities like Business Analysis, Risk Identification, FRS creation and other validation testing deliverables.
Good understanding & practical experience of 21CFR Part 11 and other FDA GxP regulations.



Additional Skills

Excellent verbal and written communication skills
Experience in consulting domain to handle/manage different clients Qualifications
B.E./B.Tech./MCA/MBA/M.Sc/B.Pharm/M.Pharm
Professional Qualification - Computer System Validation
Experience 6 - 9 Years Your role as a leader At Deloitte India, we believe in the importance of leadership at all levels. We expect our people to embrace and live our purpose by challenging themselves to identify issues that are most important for our clients, our people, and for society and make an impact that matters.


In addition to living our purpose, across our organization:


Acts as a role model, embracing and living our purpose and values, and recognizing others for the impact they make
Develops high-performing people and teams through challenging and meaningful opportunities
Delivers exceptional client service; maximizes results and drives high performance from people while fostering collaboration across businesses and borders
Influences clients, teams, and individuals positively, leading by example and establishing confident relationships with increasingly senior people
Understands key objectives for clients and Deloitte, aligns people to objectives and sets priorities and direction.


How youll grow At Deloitte,
our professional development plan focuses on helping people at every level of their career to identify and use their strengths to do their best work every day. From entry-level employees to senior leaders, we believe theres always room to learn. We offer opportunities to help build world-class skills in addition to hands-on experience in the global, fast-changing business world. From on-the-job learning experiences to formal development programs at Deloitte University, our professionals have a variety of opportunities to continue to grow throughout their career.