QA Specialist

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 Novar tis 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 aretaken

• 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 technicalcomplaintsforallNovartisCorporate products accordingto respective SOP

Essential Requirements:

• Minimum 1 year of experience in a pharmaceutical manufacturer or importer

• Licensed Pharmacist (mandatory for Import Manager registration and execution of batch release responsibilities)

• Demonstrated ability to proactively manage diverse operational issues, collaborating effectively with internal and external stakeholders to drive resolution

• Experience in leading and uniting teams toward shared goals, fostering an inclusive environment that respects diversity and motivates team members

• Good command in English (speaking and writing)

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:

Novartis are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potentia

 

Skills Desired

Analytical Thinking, Change Management, Collaboration, Communication Skills, Data Integrity, Data saviness, Dealing With Ambiguity, Digital saviness, Good Documentation Practice, Leadership, Problem Solving Skills, Regulatory Requirements knowledge