TAIWAN QA Specialist TWHKMO

• Perform and/or support the management of quality operations for Santen in responsible country (Taiwan Hong Kong Macau) to ensure its compliance with applicable local regulatory authority and Santens global requirements for importation local testing repackaging storage and distribution of Santen products.
• Provide support to develop implement and maintain a fit for purpose local QMS as per applicable to support country quality operation/activities in responsible country.
• Provide support to Quality Management Representative for Santen in responsible country and so as to ensure the development implementation and maintenance of a systematic effective and efficient local Quality Management System (QMS) as per applicable local regulatory authority and Santens global requirements.
• Provide support to the management of all relevant regulatory inspections or certification audits for responsible country (GDP/GDPMD by regulators or certification body) to ensure successful maintenance / renewal of license and certification. 
• Provide support to prepare/facilitate all relevant regulatory inspections or certification audits for relevant CMO in responsible country (CMO site inspection by regulators or certification body) to support successful maintenance / renewal of license and certification. 6. Provide support to the management of external/internal audit program for Santen in responsible country as per applicable local regulatory and Santen global requirements.
• Perform/support quality activities and resolve quality issues for Santen in responsible country to support the continuous supply of Santen products in these countries in compliance to applicable local regulatory authority and Santens global/release requirements.
• Ensure all relevant quality support are provided for all relevant post market activities for Santen in responsible country are executed timely as per applicable local regulatory authority and Santens global requirements so as to minimize interruption to supply of quality compliant product. 9. Provide support to the management of chemical reagents and reference standard to ensure its continuous supply for local product testing (if required).
• Provide support to all relevant quality input/support to business projects new product introduction product launches and product variation in responsible country are provided timely.
• Represent Asia QA team to provide relevant QA input/support to selected business projects/initiatives if required.
• Provide support to other APAC countries quality operations if required.

Qualifications :

• Degrees in a relevant field; Science degree is a plus
• Min. 24 years experience in Pharmaceutical and/or Medical Device Company in quality function with 12 years in GMP manufacturing plant environment with 12 years in commercial Quality environment.
• As per Taiwan regulatory requirements on Good Distribution Practice (GDP) or Good Distribution Practice for Medical Device (GDPMD) and NMC corporate standards is preferred.
• Some knowledge and experience working with regulators and local distributors on local product testing issues resolution and management. Some knowledge of local regulatory requirement on local product secondary packaging and local product testing.
• Good knowledge and experience on managing/performing quality operation activities and the regulatory requirements for the importation repackaging release storage and distribution of pharmaceutical and medical devices products (including sterile liquid/solid products and cold chain) is preferred.
• Proven knowledge and experience in working with cGMP and quality management system elements and guidelines (e.g. PIC/s ICH ISO9001 or ISO 13485 and cold chain product repackaging.
• Experience in managing supplier audits internal audits regulatory authority inspections.
• Experience on quality management or oversight of CMO is a plus.

Additional Information :

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our longterm vision outlined in Santen 2030 we are committed to be a Social Innovator addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes education and treatment. At Santen we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer.  We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs role requirements and individual qualifications regardless of race color ethnicity national origin/ancestry religion sexual orientation gender gender identity/ expression age disability medical condition marital status veteran status or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process please let the recruiter from our team know.

*Please note that team assignments may be subject to future changes

Remote Work :

No

Employment Type :

Fulltime