※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Position] QA Specialist
[Salary] 8〜10 million JPY ※Experiences and skills will be considered
- Performs a wide variety of activities to ensure compliance with Good Quality Practices (GQP) and Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
- Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
- Maintains routine programs and processes to ensure high quality products and compliance with current GQP/GMP/GDP
- Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
- Normally receives very little instruction on routine work, general instructions on new assignments.
- May act as a mentor to QA contactor with some task management responsibility.
- May participates in cross-functional teams
◆Key Differentiating Contributions
- Conducts final reviews prior to batch release approval by manager.
- Works on routine QA operations such as Release, Change Control, Deviation, Product Complaint,
- Quality Documents creation and revision, training.
- Works on non-routine projects/assignments where analysis of situation or data requires a review of identifiable factors.
- Exercises judgment within well-defined and established procedures and practices to determine appropriate action - identifies problems and generates alternatives and recommendations within defined processes.
- Leads and coordinates reviews and investigations in situations involving deviations from governing procedures and processes.
- Coordinates planning, organization, and implementation of projects within specified objectives.
- GQP-tasks Responsible Managers role
◆Knowledge, Experience & Skills
- Demonstrates working knowledge of quality assurance systems, methods and procedures.
- Demonstrates thorough knowledge of GQP/GMP/GDP, and the interface with other functions like manufacturing, distribution and maintenance.
- Demonstrates audit and investigation skills, and report writing skills.
- Demonstrates strong verbal, technical writing and interpersonal skills.
- Demonstrates proficiency in Microsoft Office applications.
- Excellent Japanese and English general communication skills
- Knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations is preferred.
◆Typical Education & Experience
- 4+ years of QA relevant experience in pharmaceutical or chemical related field and a BS or 2+ years of relevant experience and a MS.
- Prior experience in pharmaceutical industry is preferred.
- Moderate knowledge and experience in analytical, process chemistry and/or formulation development
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance