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, on-time delivery and right first-time 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 execution of analytical equipment changes and process improvements.
- Execution 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.
- 5-10 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 inter-departmentally 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.