Senior CSV Consultant

Job Title / Designation: Senior CSV Consultant

Job Responsibilities:

·         Responsible for theory and content of validation documents and reports for software validation, changes, on-going review, and revalidation, as requested by the client

·         Establish cost-efficient and time-efficient methods of performing Computer System Validation activities as well as Data Integrity initiatives.

·         Responsible for creation, execution and review of validation packages as per Client’s requirements.

·         Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply.

·         Ensure system qualification/validation documentation is in compliance with Client policies and procedures, as well as meet regulatory requirements.

·         Responsible for providing training to client SMEs on best practices as well as building a robust Computer System Validation and Data Integrity Culture within Client’s organization.

·         Ensure System Backup and System Audit Trail Verification tests are conducted as per client’s guidelines

·         Execute Data Integrity protocol and Electronic Records and Signatures Assessment

·         Assist other team members in creation, review and implementation of Standard Operating Procedures required for maintaining system validated state.

·         Single point of Accountability for specific Computer System Validation Project.

·         For Manufacturing CSV Expert specifically, must possess knowledge of system alarms and recipes; and have experience in both Software Validation as well as integrated equipment-software qualification tests to demonstrate robustness of controls in place.

·         For Laboratory CSV Expert specifically, must possess prior experience in validating standalone laboratory systems.

·         For Empower 3 CSV Expert specifically, must possess prior experience and knowledge in validation and implementation of Empower 3 across the network, custom field creation and validation, and training module creation and implementation.

·         Must maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11).

·         Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.

Must be willing to travel regionally and/or nationally throughout India

Experience in creation of system validation test scripts and execution of system validation lifecycle deliverables- mandatory.

Experience in project execution within at least one area of systems validation (e.g. laboratory equipment, facilities utilities, manufacturing equipment).

Prior experience in conducting System Backup testing mandatory.

For Manufacturing CSV SME, prior experience in validation of PLCs, DCS and SCADA preferred.

For Manufacturing CSV SME, prior experience dealing with alarms and recipe management preferred.

For Laboratory CSV SME, prior experience in validation of GxP Laboratory Systems preferred.

For Empower 3 CSV SME, prior experience in validation of Empower 3 and custom field creation/validation needed. In addition, SOP & training creation and implementation experience preferred.

Candidates must have excellent verbal communication and technical writing skills.

Experience in generation and execution of protocols and procedures, related to different areas of qualification and validation.

Candidates must demonstrate expertise in ISPE GAMP5, ICH Q8, ICHQ9, ICH Q10 and 21 CFR part 11, Computerized System Validation, Equipment Qualification, Validation Change Control, Data Integrity Assessments and System Backup.

Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents.

Proficient in Microsoft Word, Excel, Power Point and Project

Ability to plan and manage own work

All candidates must be legally eligible to work in India

Minimum/Maximum/ Work Experience Required: 10+ years.

Annual CTC:  Not a Constraint

Location(s) of Job: Vishakhapatnam/Vizag

Minimum Education Requirements: BS Degree; Computer Science preferred.

No of rounds of Interviews: 3

Work Timings: 8 AM – 5 PM; 6 days per week.