Business Process Architect

 About The Role  



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

3 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, representing validation team in internal and client meetings, providing coaching to the team, develop and maintain validation documentation.
Roles & Responsibilities:

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

Strong analytical skills to assess business processes and identify areas for improvement.

Ability to communicate effectively

Additional Information:

The candidate should have minimum 4 years of experience in Computer System Validation (CSV).

BE or equivalent , a 15 years full time education is required.

 Qualification 15 years full time education