Novartis

Global pharmaceutical company delivering science-based innovations

Quality Assurance Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeSeoul, South KoreaNo salary listedIn-person

About the Job

Requirements

A degree in Pharmacy is required.
Registration as a pharmacist in Korea is required.
A minimum of 3 years of pharmaceutical-industry experience in a relevant field such as quality assurance, quality control, registration, production, or a directly related area is required.
Good command of English, speaking and writing, is required.
Strong interpersonal skills are required.
Strong project management and leadership skills are required.
Ability to work under pressure and in a matrix organization is required.
Highly proficient negotiation skills are required.
Highly effective influencing skills are required.

Responsibilities

Ensure finished products imported and distributed by the country organization comply with Korea Pharmaceutical Law and related regulations, Novartis Corporate Quality Manual and Policies, relevant standard operating procedures, and cGxP requirements.
Ensure product compliance with local and international regulations and Novartis Corporate Quality Policy.
Ensure drug products are released to market in a timely manner in accordance with registered specifications and local and international regulations.
Manage the Change Control process effectively.
Manage documentation and archiving of quality assurance data and records in compliance with local regulations, Novartis corporate guidelines, and good manufacturing practice requirements.
Review the alignment of analytical testing specifications and methods with the registered product license.
Manage analytical method transfers and analytical testing document transfers in accordance with Novartis Quality Manual and Quality Directives, relevant standard operating procedures, and 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 corrective and preventive actions promptly.
Manage technical complaints, including reporting them to appropriate investigation sites, managing investigation processes, and ensuring appropriate corrective actions are taken.
Identify and report quality or compliance concerns and implement immediate corrective action as required.
Ensure readiness for escalation, including prompt decisions and actions relating to recalls or market actions.
Report monthly Key Quality Indicators, monitor them, and ensure gaps are addressed appropriately to mitigate risk.
Establish effective working relationships with Supply Chain Management, Regulatory Affairs, and External Supply Organization to maintain quality assurance oversight of partners and third-party activities.
Ensure returned and defective products are managed and disposed of in accordance with good manufacturing practice requirements.
Ensure reporting and follow-up of all spontaneous adverse events and technical complaints for Novartis Corporate products according to the relevant standard operating procedure.
Maintain and continuously update the local good manufacturing practice quality system as required.
Proactively identify and effectively mitigate good manufacturing practice-related risks.
Conduct training according to the program.

Desired Qualifications

No qualifications are explicitly identified as preferred; the listed desired skills include analytical thinking, audit inspections, business awareness, change adoption, communication, data integrity, data literacy, good manufacturing practice compliance, managing ambiguity, operational excellence, problem solving, process optimization, product distribution, quality assurance, quality management systems, regulatory awareness, regulatory compliance, and stakeholder management.

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 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.

Key Performance Indicators (KPIs)

Local GMP Quality System in place and continuously updated, as required
GMP related risks proactively identified and effectively mitigated
The number and severity of GMP issues identified during internal and external audits
No regulatory problem/action due to inefficient local Change Control procedure
Training conducted according to program

Education

Degree in Pharmacy
Registered Pharmacist in Korea is required

Language

Good command in English (speaking and writing)

Experience

Min. 3 year experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, production or a directly related area
Strong Interpersonal skills
Strong Project Management and leadership skills
Ability to work under pressure and matrix organization
Highly proficient in negotiation skills
Highly effective in influencing others

Skills Desired

Analytical Thinking, Audit Inspections, Business Awareness, Change Adoption, Communication, Data Integrity, Data Literacy, GMP Compliance, Managing Ambiguity, Operational Excellence, Problem Solving, Process Optimization, Product Distribution, Quality Assurance (QA), Quality Management Systems (QMS), Regulatory Awareness, Regulatory Compliance, Stakeholder Management

About the Company

Novartis

Global pharmaceutical company delivering science-based innovations

Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.

Company size: 10,001+
Company stage: IPO
Headquarters: Basel, Switzerland
Founded: 1970

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