QC Analyst, Sucampo Pharma (Sanda, Hyogo)

Job Title

QC Analyst, Sucampo Pharma (Sanda, Hyogo)

Requisition

JR000013827 QC Analyst, Sucampo Pharma (Sanda, Hyogo) (Open)

Location

Sanda – JPN305

Additional Locations

Sanda

Job Description

The Quality Control (QC) Analyst is responsible for QC testing within the laboratory to support the API Manufacturing Facility. Location of the facility is Sanda, Hyogo prefecture, Japan. The role will ensure adherence with GMP while delivering consistently for the internal and external customers.

• Testing of routine release of raw materials, intermediates, finished product (API) and stability
• Draft and review documentation – SOPs, protocols, training modules, investigations, reports and QMS documents (OOS/OOT, Deviation, Change Control, Validation etc.)
• Experience with chemistry, GC, HPLC and a willingness to learn new analytical techniques as the laboratory evolves
• Work within the test schedule for the facility and the stability programs
• Day to day activities required for running of the laboratory

Education / Experience / Skills:

• Minimum 3 years’ experience in a similar role
• Working under cGMP regulation at least 3 years
• Solid experience of HPLC and GC preferred
• Self-starter with strong work ethic
• Good interpersonal skills are required, as is the ability to communicate well, both verbally and written by using Japanese.
• Must be able to function effectively in a teamwork environment
• Ability to identify, execute and prioritize work tasks/projects and know when to escalate
• Excellent problem-solving, decision-making and communication skills
• Good computer skills, including proficiency with business and technical software (Word, Excel, PowerPoint, etc.)
• Ability to plan, organize, and prioritize effectively
• High levels of integrity and trustworthiness

Organizational Relationship/Scope:

Reporting to the QC manager. The QC Analyst is required to perform testing and analysis within QC. The QC Analyst works closely with Senior QC Analysts within the lab and cross functionally with QA and Manufacturing across Sanda facility.

Working Conditions:

Flex time, Standard working time: 7h50min/day, Core time 10:00-15:00

Lab: 95%, Remote Working: 5%

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