Full Stack Engineer

Business Process Architect

Project Role : Business Process Architect
Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs.
Must have skills : Computer System Validation (CSV)
Good to have skills : NA
Minimum 5 year(s) of experience is required
Educational Qualification : 15 years full time education

Summary:
As a Business Process Architect, you will represent the compliance/validation team to perform End-to-End CSV in GxP environment. Your typical day will involve collaborating with various stakeholders, represent validation team in internal and client meetings, providing coaching to the team, develop and maintain validation documentation.

Roles & Responsibilities:
- Expected to be an SME.
- Lead teams and perform project validation activities
- Develop and maintain comprehensive documentation of business processes and workflows.
-Represent the compliance / validation team in internal meetings and gather data for metrics to report to management
- Provide coaching to the teams to ensure that they understand and consistently follow client processes and validation objectives
- Understand FDA and other regulatory guidelines
- Collaborate and manage the team to perform.
- Responsible for team decisions.
- Engage with multiple teams and contribute on key decisions.
- Provide solutions to problems for their immediate team and across multiple teams.
- Facilitate workshops and meetings to gather requirements and feedback from stakeholders.

Professional & Technical Skills:
- Knowledge of End-to-End CSV in GxP environment with deep experience in validation life cycle and V-Model
- Knowledge of Pharma Regulatory Compliance and CSV/CSA across various regulatory bodies viz FDA, EMEA etc
- Good understanding of Pharma Regulatory requirements including CFR Part 11 and GAMP5 guidelines
- Ability to write SOPs/Work Instructions
- Experience in V-Model and Validation life cycle of regulated projects e: GxP Awareness including Good Documentation Practices
- Experience in external audit support preferred
- Strong analytical skills to assess business processes and identify areas for improvement.
- Experience in process mapping and documentation techniques.
- Ability to communicate effectively with both technical and non-technical stakeholders.
- Familiarity with project management methodologies and tools.


Additional Information:
- The candidate should have minimum 7 years of experience in Computer System Validation (CSV).
- This position is based at our Bengaluru office.
- BE or equivalent, a 15 years full time education is required.