RA-CSR-Cyber-CS-CSV

1 month ago

Pune, India Deloitte Full time

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 you’ll do

 As a part of our Risk Advisory team you’ll build and nurture positive working relationships with teams and clients with the intention to exceed client expectations.

You’ll:

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 you’ll 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 there’s 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.

  • RA-CSR-Cyber-CS-CSV

    4 weeks ago

    pune, India Deloitte Full time

    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 you’ll do  As a part of our Risk...

  • RA-CSR-Cyber-CS-AM ISMS

    1 week ago

    Pune, India Deloitte Full time

    What impact will you make?Every day, your work will make an impact that matters, while you thrive in a dynamic culture of inclusion, collaboration and high performance. As the undisputed leader in professional services, Deloitte is where you’ll find unrivaled opportunities to succeed and realize your full potentialDeloitte is where you’ll find unrivaled...

  • RA-CSR-Cyber-CS-AM ISMS

    1 week ago

    Pune, India Deloitte Full time

    What impact will you make? Every day, your work will make an impact that matters, while you thrive in a dynamic culture of inclusion, collaboration and high performance. As the undisputed leader in professional services, Deloitte is where you’ll find unrivaled opportunities to succeed and realize your full potential Deloitte is where you’ll find...

  • RA-CSR-Cyber-AS-SAP GRC

    2 weeks ago

    Pune, India Deloitte Full time

    What impact will you make?Every day, your work will make an impact that matters, while you thrive in a dynamic culture of inclusion, collaboration and high performance. As the undisputed leader in professional services, Deloitte is where you’ll find unrivaled opportunities to succeed and realize your full potentialThe TeamDeloitte helps organizations...

  • RA-CSR-Cyber-AS-SAP GRC

    2 weeks ago

    Pune, India Deloitte Full time

    What impact will you make? Every day, your work will make an impact that matters, while you thrive in a dynamic culture of inclusion, collaboration and high performance. As the undisputed leader in professional services, Deloitte is where you’ll find unrivaled opportunities to succeed and realize your full potential The Team Deloitte helps...

  • RA-CSR-Cyber-AS-SAP GRC

    2 weeks ago

    pune, India Deloitte Full time

    What impact will you make? Every day, your work will make an impact that matters, while you thrive in a dynamic culture of inclusion, collaboration and high performance. As the undisputed leader in professional services, Deloitte is where you’ll find unrivaled opportunities to succeed and realize your full potential The Team Deloitte helps...

  • QA/RA Manager

    1 week ago

    pune, India Medorah Meditek Pvt Ltd Full time

    Job Title : QA/RA ManagerLocation : Gurugram // Delhi -NCRJob Description:·  Manage the QA/RA team·  Author and refine procedures, instructions, templates, and our quality manual to maintain quality management standards.·  Maintain and monitor our quality system within the company: changes, CAPA, Non-conformities, Complaints, PMS, continuous...

  • QA/RA Manager

    1 week ago

    Pune, India Medorah Meditek Pvt Ltd Full time

    Job Title : QA/RA Manager Location : Gurugram // Delhi -NCR Job Description: ·  Manage the QA/RA team ·  Author and refine procedures, instructions, templates, and our quality manual to maintain quality management standards. ·  Maintain and monitor our quality system within the company: changes, CAPA, Non-conformities, Complaints, PMS,...

  • QA/RA Manager

    1 week ago

    Pune, India Medorah Meditek Pvt Ltd Full time

    Job Title : QA/RA ManagerLocation : Gurugram // Delhi -NCRJob Description:·  Manage the QA/RA team·  Author and refine procedures, instructions, templates, and our quality manual to maintain quality management standards.·  Maintain and monitor our quality system within the company: changes, CAPA, Non-conformities, Complaints, PMS, continuous...

  • RA-CSR-Cyber-AS-SAP BRIM 1

    2 weeks ago

    Pune, India Deloitte Full time

    What impact will you make? Every day, your work will make an impact that matters, while you thrive in a dynamic culture of inclusion, collaboration and high performance. As the undisputed leader in professional services, Deloitte is where you’ll find unrivaled opportunities to succeed and realize your full potential Job Description ...

  • RA-CSR-Cyber-AS-SAP BRIM 1

    2 weeks ago

    pune, India Deloitte Full time

    What impact will you make? Every day, your work will make an impact that matters, while you thrive in a dynamic culture of inclusion, collaboration and high performance. As the undisputed leader in professional services, Deloitte is where you’ll find unrivaled opportunities to succeed and realize your full potential Job Description ...

  • Cyber Security/ Ceh Trainer

    4 weeks ago

    Pune, India Blueteam Cyber Security Labs Full time

    **Job description** - **can take corporate and classroom regular training batches of students and professionals**: - Training Students on Footprinting and Reconnaissance, Scanning Networks, Enumeration, Vulnerability Analysis, System Hacking, Malware Threats, Sniffing, Social Engineering, denial of Service, Session Hijacking, Evading IDS, Firewalls and...

  • SAP SD/CS Consultant

    2 weeks ago

    Pune, India Rieter Full time

    Your Main Tasks and ResponsibilitiesConfigure and customize SAP SD/CS, E-Commerce, and Local taxation solutions (GST, TDS) to support business processes and requirements.Collaborate with business stakeholders to gather and analyze requirements and translate them into SAP solutions.Provide end-to-end implementation and support of SAP SD/CS modules,...

  • SAP SD/CS Consultant

    3 weeks ago

    Pune, India Rieter Full time

    Your Main Tasks and Responsibilities Configure and customize SAP SD/CS, E-Commerce, and Local taxation solutions (GST, TDS) to support business processes and requirements. Collaborate with business stakeholders to gather and analyze requirements and translate them into SAP solutions. Provide end-to-end implementation and support of SAP SD/CS...

  • SAP SD/CS Consultant

    3 weeks ago

    pune, India Rieter Full time

    Your Main Tasks and Responsibilities Configure and customize SAP SD/CS, E-Commerce, and Local taxation solutions (GST, TDS) to support business processes and requirements. Collaborate with business stakeholders to gather and analyze requirements and translate them into SAP solutions. Provide end-to-end implementation and support of SAP SD/CS...

  • Cyber Security Manager

    4 weeks ago

    Pune, India Sensata Technologies Full time

    As a Cyber Security Manager, you will be responsible for leading security-related projects according to ISO/SAE 21434, UN R155, and UN R156 together with the Project Manager and execute the projects according to those standards.You will work with our global development teams and OEM customers to perform TARA analysis, concept design for cyber security...

  • Cyber Security Authority

    4 weeks ago

    Pune, India Vodafone Full time

    **Description**: - The Cyber Security Authority delivers cyber security activities, aligning global cyber security risk reduction with local market business and technology priorities and in line with the global cyber security strategy to be implemented in the local market/s.The Cyber Security Authority focusses on activities that protect Vodafone from...

  • Cyber Security Manager

    1 month ago

    pune, India Sensata Technologies Full time

    As a Cyber Security Manager, you will be responsible for leading security-related projects according to ISO/SAE 21434, UN R155, and UN R156 together with the Project Manager and execute the projects according to those standards.You will work with our global development teams and OEM customers to perform TARA analysis, concept design for cyber security...

  • Cyber Security Manager

    1 month ago

    Pune, India Sensata Technologies Full time

    As a Cyber Security Manager, you will be responsible for leading security-related projects according to ISO/SAE 21434, UN R155, and UN R156 together with the Project Manager and execute the projects according to those standards. You will work with our global development teams and OEM customers to perform TARA analysis, concept design for cyber security...

  • CSV Consultant

    7 days ago

    Pune, India Quantum Integrators Full time

    Company Profile: Quantum Integrators is an international strategy and business consulting group whose mission is to help clients create and sustain competitive advantage. As a truly client-focused firm, our highly trained and experienced consultants consider it their mandate to help client organizations achieve a 'quantum state.Role: CSV Consultant (Computer...