Computer System Validation

Job Description: Computer System Validation Specialist (Veeva QMS)

Location: Hyderabad

Shift Timings: 6:30 PM 3:30 AM (EST Time Zone)

Job Description:

Must have 5-6 years experience operating as a CSV specialist.

Minimum of 2 years experience in 21 CFR Part 11- Good understanding of 21 CFR Part 11, EU Annex 11, Part 210, Part 820, ISO 13485, USP-EP guidelines, ICH Q7 - Q10, GAMP 5 ( these are all common practices in the CSV world).

Working experience with Veeva QMS.

Solid experience with diverse Quality Management programs, Change Management, CAPA management, Deviation Management, Risk Management, etc. for stand-alone, computerized laboratory, and manufacturing.

In-depth understanding and practical knowledge of the Software Development Life Cycle (SDLC), Validation Life Cycle and Qualification Methodologies.

Orchestrate complex validation efforts from concept to completion, requiring significant cross-functional coordination across multiple areas of concern regarding compliance and regulatory risk.

Experienced in authorship, review, and approval of various Validation and Qualification deliverables such as plans, specifications, assessments, protocols, trace matrices, reports, procedures, work instructions, training plans, etc.

Solid experience with diverse Quality Management programs viz. Change Management, CAPA management, Deviation Management, Risk Management, etc. for stand-alone, computerized laboratory, and manufacturing systems.

Good understanding of 21 CFR Part 11, EU Annex 11, Part 210, Part 820, ISO 13485, USP-EP guidelines, ICH Q7 - Q10, GAMP 5, and expertise in Gap Analysis, leading Remediation efforts, Decommissioning efforts, Periodic Review programs, Account Administration for

Systems, Data Integrity Assessments, Data and System Audit Trail Reviews.

Lead commissioning, qualification, and validation efforts for enterprise projects create work breakdown structures, support project managers with budget estimation and project scheduling, resource management, and dependency management to propel projects to on-time completion with little to no Slack.

Ability to hit the ground running, resolve conflicts, absorb pressure, coach individuals for continuous improvement, lead by example, and work efficiently in both individual and team-based environments.

Excellent communication and organizing skills with the ability to grasp and learn new technology quickly.

Additional Skills & Qualifications:

veeva validation