O

Opella

Global OTC & VMS self-care manufacturer

Quality Assurance Operational Support

Regulatory & Quality (Life Sciences)Updated on Nov 14
Full-timeNarita, Chiba, JapanNo salary listed

About the Job

Requirements

  • A university degree, or equivalent general education together with knowledge of quality assurance and quality control.
  • At least five years of quality assurance work experience.
  • General knowledge of pharmaceutical sciences and physical sciences, including analytical chemistry, organic chemistry, and statistics.
  • Basic knowledge of formulation science and products.
  • Knowledge of validation processes.
  • Knowledge of computerized system validation.
  • Ability to use Microsoft Word, Excel, and PowerPoint.

Responsibilities

  • Analyze quality assurance matters and problems, communicate findings to relevant departments and related companies, and coordinate appropriate solutions.
  • Build, maintain, and manage the factory quality assurance system in compliance with Japanese laws and regulations and Opella global standards.
  • Respond to global quality audits and inspections by regulatory authorities.
  • Inspect and provide guidance to raw material and packaging material suppliers.
  • Prepare, manage, revise, and retain Good Manufacturing Practice (GMP) documents.
  • Investigate causes of product quality complaints and coordinate resolutions with the factory, internal departments, and suppliers.
  • Understand relevant global documents and regulatory notifications and maintain the factory quality system accordingly.
  • Operate the GMP committee to support appropriate quality assessments within the factory.
  • Evaluate changes arising within the factory and manage their handling in coordination with related departments.
  • Identify deviations occurring within the factory, evaluate corrective actions, and manage efforts to prevent recurrence.
  • Review validation and qualification documentation and promote proper operation and assessment of equipment and machinery and assurance of manufactured product quality.
  • Provide capability-development opportunities to QA group members, identify and resolve group issues, and motivate members through teaching and coaching.

Desired Qualifications

  • Experience in a quality assurance department at a pharmaceutical manufacturing plant.
  • Ability to communicate in English by email and face-to-face; TOEIC score around 800.
  • Experience using Microsoft Power Platform, including Power BI, Power Apps, or Power Automate.
  • Knowledge of Japanese regulations and guidelines, including the Pharmaceuticals and Medical Devices Act and GMP ministerial ordinance.
  • Pharmacist license.

About the Company

Opella

Global OTC & VMS self-care manufacturer

Opella makes a wide range of over-the-counter medicines, vitamins, minerals, and supplements for global consumers, covering about 100 brands and an 11,000-strong workforce. It develops, manufactures, and markets non-prescription health products that people can buy ready-made in stores for common needs such as pain relief, digestion, and allergy relief. The company differentiates itself with a large global manufacturing footprint (13 sites and 4 science and innovation centers) and its B Corp certification, signaling accountability to social and environmental standards. Its goal is to simplify self-care and put health in people’s hands for half a billion consumers worldwide.

Company size
5,001-10,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Neuilly-sur-Seine, France
Founded
2018

Recently Posted Jobs

Explore more opportunities at Opella

See more jobs