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:
A leadership-oriented Computerized System Validation (CSV) and Computer Software Assurance (CSA) professional responsible for guiding small teams through end-to-end validation activities in a GxP-regulated environment. This role involves acting as the face of the compliance team, developing Standard Operating Procedures (SOPs), ensuring adherence to global regulatory standards (including FDA, EMEA, 21 CFR Part 11, and GAMP5), and actively supporting external regulatory audits.
Roles & Responsibilities:
- Team Leadership & Execution: Guide and manage small teams while actively performing and overseeing project validation activities.
- Representation & Reporting: Act as the primary liaison for the compliance/validation team during internal meetings, taking charge of gathering data and reporting compliance metrics to management.
- Team Mentorship: Coach and mentor team members to guarantee complete understanding and consistent execution of client workflows and project validation targets.
- Regulatory Oversight: Maintain a comprehensive and up-to-date understanding of FDA and other global regulatory guidelines.
Professional & Technical Skills:
- Global Regulatory Knowledge: Deep expertise in Pharmaceutical Regulatory Compliance and CSV/CSA across major regulatory bodies (e.g., FDA, EMEA).
- End-to-End Validation: Comprehensive knowledge of full-cycle CSV within GxP environments, featuring extensive hands-on experience with the V-Model and the complete validation lifecycle for regulated projects.
- Industry Frameworks: Strong grasp of pharmaceutical regulatory mandates, specifically focusing on 21 CFR Part 11 and GAMP5 guidelines.
- Technical Writing: Proven ability to author, develop, and refine Standard Operating Procedures (SOPs) and Work Instructions.
- Documentation Standards: High level of GxP awareness, including strict adherence to Good Documentation Practices (GDP).
- Audit Support: Practical experience preparing for, participating in, and supporting external regulatory audits.
- Communication & Analysis: Exceptional analytical capabilities paired with strong, clear communication skills.
- Leadership & Critical Thinking: Demonstrated leadership qualities combined with effective problem-solving and troubleshooting abilities.
- Ability to collaborate with diverse teams and stakeholders to gather and validate requirements.
- Excellent problem-solving skills to address challenges during process design and implementation.
- Familiarity with regulatory and compliance considerations related to system validation.
Additional Information:
- Degree: Bachelor of Engineering (BE) degree or an equivalent academic credential.
- The candidate should have minimum 7 years of experience
- This position is based at our Bangalore office.
- A 15 years full time education is required.
