- This individual is responsible for quality oversight of the GxP computer systems used in the manufacturing and laboratory areas at the Brooklyn Park site of Takeda.
- As part of the computer System Development Life Cycle (SDLC), this person analyzes the quality system needs of applicable business stakeholders and to identify business problems/gaps to assist the site to implement application-based solutions.
- This person may support and/or represent the Quality Assurance functional area as a subject matter expert (SME) during regulatory and third party inspections.
- This position is responsible conducting validation reviews and provide compliance oversight for laboratory and manufacturing systems and equipment used for cGMP purposes.
- Reviews and approves process, assay, and other validation protocols and reports thoroughly, with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls.
- Participates in the audit or inspection of vendors or partner organizations relative to their creation of computer system products, use of computerized systems, or calibration, preventive maintenance and equipment qualification service, as assigned by management.
- Reviews proposed changes to validated systems and assists with the identifcation of validation requirements necessary to maintain the system s validation status after execution of the change.
- Represents QA on cross-functional project teams such as tech transfer, process validation, and process improvements.
- Identifies, investigates, and resolves complex technical issues using problem-solving skills. Notifies management of actions taken.
- Analyzes and interprets projects, studies, or investigations to determine next steps. Makes decisions independently and notifies management of action taken.
- Writes new documents and revises existing documents, independently.
- Performs QA review/approval of controlled documents.
- Receives minimal supervision on work assignments. Receives overall project direction from management, but completes most work independently.
- Participates in internal audits as needed.
- Develops and provides training on department-specific procedures and systems.
- Participates in required training and keeps training files current.
- Identifies, proposes, and implements Quality Process and system improvements.
- Performs additional duties, as assigned.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BA/BS (or Master's) in any Life Science discipline preferred, and/or 5+ years experience in Regulated (food, medical device, or pharma/biotech) industry.
- Wrist and hand motion (e.g. typing, writing)
- Willingness to travel to various meetings or client sites, including overnight trips
- Requires approximately 0-5% travel
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