What are the responsibilities and job description for the QA Lead Technical Operations position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions.
- Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations.
- Reviews and approves Quality, Quality Control, Validation and Automation related documents.
- Review and approve Standard Operating Procedures (SOPs).
- Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports.
- Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.
- Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.
- Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment.
- Able to interpret complicated data and make sound decisions, independently.
- This position will regularly interact with the Reporting Manager.
- Quality Control.
- Manufacturing Operations.
- Manufacturing Engineering.
- Manufacturing Science and Technology (MS&T).
- Validation.
- Site Engineering.
- Digital Plant.
Requirements :
