What are the responsibilities and job description for the GMP Operational Quality, Specialist/Senior Specialist (QA Analytical) position at LS Solutions?
Job Description
Job Description
JOB DESCRIPTION
Position Overview :
The GMP Operational Quality Specialist / Senior Specialist works with a high degree of independence to provide QA Analytical support for the release of commercial products. The GMP Operational Quality Specialist executes routine tasks and activities in support of QA Analytical function.
Key Responsibilities :
- Provides QA review of the GMP data in support of release of commercial product as required.
- Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function.
- Represents QA Analytical on cross-functional teams as an experienced Quality technical resource as needed
- Supports quality oversite of root-cause analysis and product impact assessment for deviation and OOS / OOT investigations. Ensure that appropriate CAPA actions are identified. May approve investigations / CAPAs
- Supports change control assessment, implementation, and closure as needed
- Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and reports
- Supports analytical method validation and transfer activities for commercial and clinical products as needed.
- Drafts and enforces Quality Agreements between CMOs / Suppliers and Vertex, as neede
- Identifies and facilitates continuous improvement effort
- Supports generations and maintenance of Quality Metrics to support process improvement activities as necessary
- Identify and communicate risks and assist with risk mitigation plans as necessar
- Supports internal audit or external audit programs as necessar
- Assists in preparation of audit responses as necessary
Required Skillset
Qualifications :
PREFFERED EDUCATION AND EXPERIENCE :
