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QA Expert / Quality_Biopharma (Atsugi）

Location: Atsugi, Kanagawa JP

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Job Number: 1129

External Description:

Your Role

QA Expert is responsible to support for establishment and maintenance of overall company's Quality systems at Atsugi site, secondary packaging site of drug products.

The QA Expert is accountable for the quality and GMP compliance of:

・Execute local quality control tests including check of packaging component and certificate of analysis according to product specifications and related working instructions.

・Maintain product specifications to ensure compliance with approval matters.

・Maintain local quality documents to assure documents are in line with its global standard as well as local regulatory requirement.

・Support training execution according to the annual plan and maintain the training matrix is up-to-date.

・Manage site change control project to assure the change is implemented in a timely manner.

・Execute self-inspection and supplier audit.

・Execute investigation for quality issues such as complaints, deviation, etc. and implement CAPA in a timely manner.

・Ensure reporting and escalation of identified risks.

 

Who you are

Education/license

・Bachelor above.

・Background in pharmaceutical, chemical, physical, or related expertise.

・Pharmacist license preferred but not essential.

 

Job Specific Competencies & Skills / Work Experience

・Preferably >3 years' experience to handle quality related works under GMP/GQP/GDP/QMS for pharmaceutical, medical device, or related industry.

・Experience in participating in PMDA/Prefectural inspection or/and self-inspection preferred but not essential.

・Good negotiation skills with internal and external customers.

・Good time and priority management skills.

・Willingness and enthusiasm to learn and share knowledge.

・Continuous improvement mindset, attention to detail, organizational skills.

 

Languages

・Native level in Japanese.

・Fluent (preferred) or business (mandatory) level in spoken and written English.

 

Additional Requirements

・Basic computer skills (Word, Excel, PowerPoint etc.

Job Number: 1129

Community / Marketing Title: QA Expert / Quality_Biopharma (Atsugi）

Location_formattedLocationLong: Atsugi, Kanagawa JP