Head of QA
Attractive salary and career up in a reputable pharmaceutical firm
Work with interesting and innovative products in a well-rounded team
The client is a global leader with a long-term commitment to innovating the way patients live. The company is fast-paced, high energy organization with an aim to constantly set new standards in the industry, and currently has a strong share in most major markets already. With a well-established portfolio in Japan, the company harnesses their passion for innovation and invests heavily to the field of pharmaceuticals and devices.
- Develop and maintain a local quality system to support release of commercial product
- Conduct or supervision of quality assurance activities, including but not limited to, product release, self-inspection, training, handling of defects
- Conduct internal process audits and external supplier audits as necessary
- Control of documents related to quality assurance activities
- Communication with necessary parties in the case of recall or discontinuation of manufacture or marketing
- Support the establishment with a compliant assurance department for investigational and commercial products
- At least 8 years of QA experience in regulated industry such as pharmaceutical,
biologics or device.
- Full understanding of GMPs and pharmaceutical development process.
- A good understanding / familiar with GLPs and GCPs and device development.
- Understanding of PMDA, FDA and European inspection procedures.
- Good Japanese and English language skills.
- Collaborate with a diverse range of clients, partners and experts in a team that places great value on your skills, talents and qualities
- Boost English language ability through close strategy collaboration with global partners
- Demonstrate leadership and team playing abilities to help people and organisations go from idea to innovation faster