Validation Specialist IV
Validation Specialist IV
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Salary Not Disclosed
1 Vacancy
Job Description
Job description:
Analytical Validation specialist IV will lead validation activities including but not limited to software updates new system introduction and decommissioning of analytical systems. This person will work closely with other functional groups like Manufacturing Operations Technology Computer System Validation Engineering and Quality Assurance to support updates to help the site remain in compliance and contribute to quality ontime delivery and right firsttime performance.
Responsibilities:
- Provide Subject Matter Expert support to Quality Control Manufacturing and other departments for the design operation and troubleshooting of analytical equipment.
- Drive/own the validation plans and of analytical equipment changes and process improvements.
- of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
- Own all forms of TW records including CC/CAPA/Deviations to support project completion.
- Generating User Requirements Specification Documentation complete Electronic Records/Electronic Signatures Data Integrity Risk Assessments and Audit Trail Risk Assessments.
- Review analytical equipment manuals and devise validation plans.
- Procurement of Analytical Equipment which includes ensuring system meets specifications quotes budgets and installations.
- Analytical Equipment Ownership.
- Identify Quality Issues involve stakeholders drive to completion/resolution.
- Participating on Risk Assessments.
- Review/Approve Commissioning Qualification Validation Documents.
- Perform other duties as assigned.
Requirements:
- Bachelor of Science related discipline or relevant experience in the field.
- 510 years of experience in Manufacturing QC Validation.
- Adherence to cGMP is required at all times during the manufacture and release of APIs.
- All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner of regulatory inspections serious GMP deficiencies process deviations product defects and relevant actions.
- Advanced technical knowledge of Quality control and manufacturing operations.
- Working knowledge and experience with Quality Systems including deviations change controls CAPAs OTNs deviations; both the system (TrackWise) and the practical applications in operations.
- Knowledgeable in process equipment cleaning and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
- Demonstrated ability to manage medium to large sized projects within required timeframes.
- Demonstrate ability for effective Planning Organizing and Controlling competency.
- Demonstrate sound decision making.
- Ability to work interdepartmentally and with customers.
- Demonstrates role model behaviors for GMP and Safety behaviors.
- Strong written and verbal communication skills.
- Ability to work in MS Project Word Excel PowerPoint.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
