Job Title: Senior Quality Assurance Specialist
Location: Japan
Industry: Pharmaceutical
Company Overview: Join our leading pharmaceutical company dedicated to advancing healthcare through innovative and high-quality products. We are seeking a dedicated Quality Assurance Specialist with a Pharmacist license to ensure our products meet the highest standards of quality and compliance.
Key Responsibilities:
- Develop, implement, and maintain quality assurance protocols and procedures in compliance with cGMP and regulatory requirements.
- Conduct regular audits and inspections of manufacturing processes to ensure adherence to quality standards.
- Review and approve production and quality control records.
- Manage and investigate quality-related issues, including deviations, non-conformances, and CAPAs (Corrective and Preventive Actions).
- Ensure proper documentation and archiving of quality assurance activities.
- Collaborate with cross-functional teams to support continuous improvement initiatives.
- Provide training and guidance to staff on quality assurance practices and regulatory requirements.
- Stay updated with the latest industry trends and regulatory changes to ensure compliance.
Qualifications:
- Licensed Pharmacist in Japan.
- Bachelor's degree in Pharmacy or a related field; advanced degrees are advantageous.
- Minimum of 5 years of experience in quality assurance within the pharmaceutical industry.
- Strong knowledge of cGMP, regulatory requirements, and quality management systems.
- Excellent analytical, problem-solving, and communication skills.
- Proficiency in Japanese and English.
- Ability to work effectively in a fast-paced, dynamic environment.
่ท็จฎ: ๅ่ณชไฟ่จผในใใทใฃใชในใ
ๅคๅๅฐ: ๆฅๆฌ
ๆฅญ็: ่ฃฝ่ฌ
ไผ็คพๆฆ่ฆ: ้ฉๆฐ็ใง้ซๅ่ณชใช่ฃฝๅใ้ใใฆๅป็ใ้ฒๅฑใใใใใจใซๅฐๅฟตใใฆใใๅฝ็คพใฎ่ฃฝ่ฌไผ็คพใซๅๅ ใใพใใใใ่ฌๅคๅธซๅ ่จฑใๆใคๅ่ณชไฟ่จผในใใทใฃใชในใใๅ้ใใฆใใพใใๅฝ็คพใฎ่ฃฝๅใๆ้ซใฎๅ่ณชๅบๆบใจ่ฆๅถใซๆบๆ ใใฆใใใใจใไฟ่จผใใๅฝนๅฒใงใใ
ไธปใชๆฅญๅๅ ๅฎน:
- cGMPใใใณ่ฆๅถ่ฆไปถใซๆบๆ ใใๅ่ณชไฟ่จผใใญใใณใซใจๆ้ ใฎ้็บใๅฎๆฝใ็ถญๆใ
- ่ฃฝ้ ใใญใปในใฎๅฎๆ็ใช็ฃๆปใจๆคๆปใๅฎๆฝใใๅ่ณชๅบๆบใฎ้ตๅฎใ็ขบ่ชใ
- ็็ฃใใใณๅ่ณช็ฎก็่จ้ฒใฎใฌใใฅใผใจๆฟ่ชใ
- ๅ่ณช้ข้ฃใฎๅ้ก๏ผ้ธ่ฑใไธ้ฉๅใๆฏๆญฃใใใณไบ้ฒๆช็ฝฎ๏ผCAPA๏ผ๏ผใฎ็ฎก็ใจ่ชฟๆปใ
- ๅ่ณชไฟ่จผๆดปๅใฎ้ฉๅใชๆๆธๅใจใขใผใซใคใใ
- ็ถ็ถ็ๆนๅใคใใทใขใใใใตใใผใใใใใใซใไป้จ้ใจๅๅใ
- ๅ่ณชไฟ่จผใฎๅฎ่ทตใจ่ฆๅถ่ฆไปถใซ้ขใใในใฟใใใธใฎใใฌใผใใณใฐใจๆๅฐใ
- ๆฅญ็ใฎๆๆฐๅๅใจ่ฆๅถใฎๅคๆดใๆๆกใใใณใณใใฉใคใขใณในใ็ขบไฟใ
่ณๆ ผ:
- ๆฅๆฌใฎ่ฌๅคๅธซๅ ่จฑใไฟๆใ
- ่ฌๅญฆใพใใฏ้ข้ฃๅ้ใฎๅญฆๅฃซๅท๏ผไธ็ดๅญฆไฝใฏๆๅฉ๏ผใ
- ่ฃฝ่ฌๆฅญ็ใงใฎๅ่ณชไฟ่จผใฎ็ต้จใๆไฝ5ๅนดใ
- cGMPใ่ฆๅถ่ฆไปถใใใใณๅ่ณช็ฎก็ใทในใใ ใซ้ขใใๅผทใ็ฅ่ญใ
- ๅชใใๅๆๅใๅ้ก่งฃๆฑบ่ฝๅใใใใณใณใใฅใใฑใผใทใงใณในใญใซใ
- ๆฅๆฌ่ชใจ่ฑ่ชใซๅ ช่ฝใ
- ่ฟ ้ใงๅ็ใช็ฐๅขใงๅนๆ็ใซๅใ่ฝๅ
