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:
A skilled Computerized System Validation (CSV) professional responsible for ensuring compliance and validating computerized systems within a GxP-regulated pharmaceutical environment. This role involves authoring crucial validation documentation, mentoring teams on regulatory standards (including FDA, GAMP5, and 21 CFR Part 11), and maintaining strict adherence to Good Documentation Practices (GDP) throughout the validation lifecycle.
Roles & Responsibilities:
- Documentation Management: Draft, evaluate, and peer-review essential validation documentation in strict accordance with Good Documentation Practices (GDP).
- System Validation: Execute and oversee compliance and validation procedures specifically tailored for computerized systems.
- Team Mentorship: Coach and guide team members to ensure they fully grasp and consistently apply client workflows and project validation goals.
Professional & Technical Skills:
- Regulatory Knowledge: Expertise in Pharmaceutical Regulatory Compliance and Computerized System Validation (CSV).
- Industry Frameworks: Strong practical background in GxP environments, encompassing the complete validation lifecycle and the V-Model framework.
- Documentation Standards: Deep understanding and application of Good Documentation Practices (GDP).
- Compliance Guidelines: Thorough familiarity with GAMP5 industry standards and FDA regulatory guidelines.
- Project Lifecycle: Proven experience managing the end-to-end validation lifecycle for highly regulated projects.
- Communication & Analysis: Excellent analytical capabilities paired with strong interpersonal communication skills.
- Critical Thinking: Highly effective problem-solving and troubleshooting abilities.
Additional Information:
- Degree: Bachelor of Engineering (BE) degree or an equivalent academic credential.
- Core Competencies: CSV, General System Validation, FDA 21 CFR Part 11 compliance, and Computerized System Validation methodologies.
- The candidate should have minimum 5 years of experience
- This position is based at our Pune office.
- A 15 years full time education is required.
Pune
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