QA System Validation Supervisor

7 days ago

Chennai Tamil Nadu, India UPS Full time

Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow—people with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level.

**Job Summary**:

- ** Knowledgeable in 21 CFR Part 11, Annex 11, and GAMP 5**:

- ** Updates validation procedures, including change control, training, and audits, to ensure the maintenance of system validation.**:

- ** Writes and reviews technical validation documents (e.g., validation plan, URS, FRS, Risk Assessment, Traceability Matrix, IQ/OQ/PQ/OPQ protocol, report, etc.)**:

- ** Assists in system validation project activities (e.g., writing protocols, reviewing/approving test scripts, drafting validation reports, etc.)**:

- ** Review and approve Change Control requests and assesses the impact on system validation status.**:

- ** Review and approve procedures, forms, and manuals.**:

- ** Perform audit trail reviews and document results.**:

- ** Perform system validation status evaluations and complete reports.**:

- ** Assist with supplier qualification assessment data gathering.**:

- ** Investigate, review, approve, and perform corrective actions for deviations (i.e., nonconformances and CAPAs) and audit findings.**:

- ** Maintains the document management system for healthcare facilities and distribution centers to ensure required documents and data are available for regulatory agency audits and inspections**:

- ** Supports internal and external audits**:

- ** Supports validation project status reports to communicate project goals, contingency plans, and issue resolutions to project teams and clients**:

- ** Supervise direct reports, as appropriate**:

- ** Lead cross functional groups**:

- ** Flexible to work in different time zones**:
**Qualifications**:

- ** Bachelor’s degree in a relevant field (e.g., Information Technology, Computer Science, Data Science, or related discipline).**:

- ** Overall, 7 years of experience with 2+ years of experience in quality assurance, manufacturing, or compliance within a GMP-regulated industry.**:

- ** Knowledgeable in 21 CFR Part 11, Annex 11, and GAMP 5**:

- ** Must be an effective collaborator and communicator**:

- ** Must be well organized**:

- ** Must have proficiency with Microsoft Excel, word and PowerPoint.**:

- ** Knowledge of Process Analysis/Continuous Improvement are required**:
**Tasks identified**:

- ** Consults with internal groups (e.g., Operations, Business Development, IT, etc.) and investigates and resolves healthcare issues to ensure compliance with rules and regulations.**:
**Employee Type**:
Permanent

UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.

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