Commercial QA Senior Specialist

Primary Function

- Individual contributor that works under limited supervision.
- Applies subject matter knowledge.
- Requires capacity to understand specific needs or requirements to apply skills/knowledge.

Core Job

- Primary responsibility is ensuring implementation of quality plan
- Implement quality assurance regulations.
- Write and revise standard operating procedures.
- Support and facilitate audits and regulatory inspections.
- Support Quality Systems are in place that meet the requirements for business needs, local regulatory authorities and Abbott Quality Assurance.
- Various specific assignment may include different aspects of quality system such as Internal audit, Training, CAPA investigations, Complaint and Product action, Documentation control, Supplier Management, Material and Distribution control, Validation, Importation and Lab testing, Distribution control, and as well as GQP requirements.
- Support Quality Assurance Manager in supervision of all quality control aspects of the process (laboratories studies, clinical research, testing, operations).
- Various specific assignment may include different aspects of quality control such as raw material testing, finished product testing, batch release review and QA hold.
- Need to be qualified as internal auditor minimally.
- Support implementation of new regulations.
- Support quality training.

Education

Degree in chemistry or pharmacy or other scientific background

Background

Quality Assurance in Pharma

Required Functional Competencies

English (if possible)

Accountability Scope

Core Jobと同じ

Required Training

Japanese Pharmaceutical GQP/GMP / 医薬品GQP/GMP