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QA System Validation Supervisor

QA System Validation Supervisor

Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

UPS Supply Chain Solutions (UPS SCS)

7 - 12 years

4 - 8 Lacs

mumbai pune gurugram

Posted:2 days ago| Platform:

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Skills Required

microsoft office applications cfr quality assurance manufacturing computer system validation capa risk management oq fda project management usfda data validation gmp gamp medical devices qms microsoft windows regulatory affairs mdr gxp

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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 tomorrowpeople 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.About The Role :
Job Summary
The Healthcare Quality Assurance (QA) System Validation Supervisor provides guidance to UPS Supply Chain Solutions (SCS) Information Technology (IT) department to maintain validation of warehouse and/or support systems utilized for healthcare applications. This position assesses systems being evaluated for use in healthcare applications and provides training and subject matter expertise to achieve and maintain validated status. He/She identifies systems requiring validation, elevates validation issues appropriately, and provides validation expertise. This position manages validation documents, determines applicable regulations, and reviews and approves testing of changes to validated systems.

About The Role

Knowledgeable in 21 CFR Part 11, Annex 11, and GAMP 5

Updates validation procedures, including change control, training, and audits, to ensure the maintenance ofsystem 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, draftingvalidation 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 ensurerequired 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 issueresolutions to project teams and clients

Supervise direct reports, as appropriate

Lead cross functional groups

Flexible to work in different time zones

Mandatory
Skills:

Proficient with Microsoft Office applications (Word, Excel, and PowerPoint)

Qualifications:

Bachelors 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:

Provides guidance to UPS Supply Chain Solutions (SCS) Information Technology (IT) and Engineering departments to maintain validation of warehouse and/or support systems utilized for healthcare applications.

Identify systems used in healthcare that require validation and assess and evaluate the applications for system validation requirements.

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

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

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UPS Supply Chain Solutions (UPS SCS)

Logistics and Supply Chain

Atlanta

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QA System Validation Supervisor