Animal health Quality Assurance - 製薬会社

Location: Tokyo
Contract Type: Permanent
Salary: ¥8000000.00 - ¥14500000.00 (年収)
Specialization: Life Science (Medical Devices / Pharmaceutical / Chemical / Healthcare / Agriculture / Livestock),
Sub Specialization: QC / QA,
Contact: Yoshiko Kumakura
Reference: JO-2208-473208

MANDATORY

  • Applicants must have permission to work in Japan
  • Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)

☑外資系企業 ☑英語力が必要 ☑フレックスタイム制 ☑リモートワーク可


[ポジション]
Animal Health Quality Assurance

[事業内容・会社の特徴]
外資系製薬会社

[仕事内容]
The purpose of the role is;

  • to ensure ongoing batch release of imported products to Japan based upon collated batch records and locally provided QC test data;
  • to ensure that Veterinary Products are manufactured, packaged, analyzed and distributed in conformance to company and regulatory guidelines and meet both internal and external customer demands.
  • Coordinate with partner manufacturing sites, inside and outside Japan to ensure ongoing supply of high quality products.

Main Responsibilities:

  • Reports to the Associate Director Quality (AH) and collaborate with Japan Quality team.
  • Receives guidance and direction when necessary; discharges all responsibilities independently. Keeps the Associate Director informed on the status of operations and when challenges, opportunities and/or issues arise.
  • Coordination of National Assay of biologics to NVAL(National Veterinary Assay Laboratory), QC testing and Batch review for imported bio and pharma products (supported by a QA technician) Product release for local markets
  • Lead and co-ordinate a Tech Transfer for Manufacturing site or QC testing (with appropriate technical support)
  • Responsible for hosting of divisional and regulatory authority audits (Global Quality, HAs and customers)
  • Conducts Quality due diligence assessments, as necessary, for pre-approval considerations of new partners according to company standard for that partner
  • Acts as AH Quality Operations point of contact to Japan third parties and as the Quality liaison between the external partner and the internal company personnel. Supports audits in the region along with subsequent remediation by the partners
  • Effectively contributes to cross-functional investigation and project teams.
  • Manage, develop and maintain TQAs with CMOs and suppliers.
  • Manage the processing and closing of the action plans for Japanese CMO audits
  • Manage complaints from Japan market and CMO deviations.
  • Audit of internal R&D and RA documents for registration.

[応募資格]

  • Bachelor degree in Pharmacy or Veterinary science or equivalent science focused area of study
  • Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements. More than 3 years professional experience in pharmaceutical company
  • Must have excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management;
  • Must have the ability to influence management of complex manufacturing operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
  • Must have expertise in manufacture, testing and release of vaccine and biological products, microbiology, sterile operations, cGMPs and regulatory issues and experience in interdisciplinary areas of pharmaceutical sciences and analytical chemistry,
  • Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organisational complexity and ambiguity
  • May have exemplary people/team leadership experience, including leading and motivating teams. Experienced in establishing performance metrics and holding people accountable for results
  • Experience and problem solving skills in biological QC.
  • Have the ability to act as GQP manager English language skills- read, write and conduct business conversations

[給与]
800万円〜1450万円
(能力・経験を考慮し当社規定により決定します。)

[就業時間]
8:45~17:30
フレックスタイム制 / 在宅勤務制度有

[待遇・福利厚生]
社会保険完備、通勤手当、退職金制度

[休日休暇]
完全週休二日制(土曜、日曜、祝日)、年末年始休暇、夏季休暇、慶弔休暇、年次有給休暇 他

[選考プロセス]
書類選考、面接数回を予定

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Reference: JO-2208-473208
#LI-REMOTE
Seniority Level:Mid Senior Level
Job Function: Quality Assurance