[Y906] - Sr. Consultant-Computer System Validation

[Y906] - Sr. Consultant-Computer System Validation

13 Nov
Edge Executive Search Pvt. Ltd.
Bangalore Rural

13 Nov

Edge Executive Search Pvt. Ltd.

Bangalore Rural

Key responsibilities:

- Minimum of 4+ years of professional experience in Life Sciences industry working for a consulting services organization.

- Lead strategic business transformation programs, manage program planning, execution and reporting; responsible for program resources, deliverables, quality, stakeholder communication, client buy-in, program risks, mitigations and budgets leading to successful program delivery and client delight

- Engage with key stakeholders; manage day-to-day interactions with client teams

- Conduct interviews/workshops/walkthroughs with subject matter experts and process owners to gather information for analysis, recommendations and for preparation of project deliverables

- Participate in sales pursuits in collaboration with larger teams; contribute to the proposal development process; proposal content creation and client presentation

- Develop solutions that enable adoption of digital capabilities for Life Sciences organizations. Participate in analyst meetings, industry speaking engagements, publish white papers/view points in leading industry journals

Your Profile

- Demonstrates proven success in roles and thorough abilities in one or more of the following areas:

1. Understanding of key Pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT

2. Subject matter expertise in areas such as Quality Management, document management and Change Management

3. Establish, implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirements

4. Knowledge of Risk management, perform root cause analysis on trends and address deviations via preventive, detective and corrective measures

5. Knowledge and hands on experience conducting periodic or control maturity assessment and Audits • Knowledge of various Validation tools and templates used throughout the Pharmaceutical industry

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