Job Description Summary

Ensure the quality of the finished products that are imported and distributed by Country Organization is complied with both a) Korea Pharmaceutical Law and the related regulation and b) Novartis Corporate Quality Manual and Policies (Quality manual and the relevant SOP) including cGxP requirements

 

Job Description

Major Accountabilities:

• Accountable for product compliance to local/international regulations as well as Novartis Corporate Quality Policy.
• Ensure that all drug products are released to the market in a timely manner in accordance with the registered specifications and with local/international regulations.
• Manage the effective Change Control process.
• Manages the documentations and archiving of QA data and records to be compliant with local regulations, Novartis Corporate guideline and GMP requirements.
• Conducts the review of the accordance between the analytical testing specifications/methods and registered product license.
• Performs management of analytical method transfer and analytical testing documents transfer complied with both Novartis QM/QD and relevant SOPs under pharmaceutical law.
• Manage external inspections, complaints, deviations, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures and implement each CAPA timely.
• Manage technical complaints including reporting to appropriate investigation sites, managing investigation processes, and ensuring that appropriate corrective actions are taken.
• Identifies and reports any quality or compliance concerns and implementation of  immediate corrective action as required
• Ensures the readiness for escalation including prompt decision and actions of recall / Market action.
• Report monthly Key Quality Indicators (KQIs) and monitor them and assure that gaps are addressed appropriately in order to mitigate risk.
• Establish a good working relationship with the Supply Chain Management (SCM) / RA departments as well as External Supply Organization (ESO) allowing to keep QA oversight on all partners (e.g. third-party activities).
• Ensures that returned and defective products are managed and disposed in accordance with GMP requirements.
• Ensure reporting and follow up of all spontaneous adverse events (AE) and technical complaints for all Novartis Corporate products according to respective SOP.

Essential Requirement

• Degree in Life Sciences or related fields
• Licensed Pharmacist, eligible to be registered as an Import Manager for the purpose of batch release approval activities.
• Min. 1 year experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, production or a directly related area.
• Proven ability to proactively and positively address complex challenges, collaborating effectively with cross-functional internal and external stakeholders to drive solutions.
• Demonstrated experience in aligning teams around shared objectives, fostering an inclusive environment, respecting diverse perspectives, and motivating others to achieve common goals.
• Good command in English (speaking and writing)

 

Skills Desired

Analytical Thinking, Change Management, Collaboration, Data Integrity, Leadership