Quality Assurance Specialist

Novartis is hiring a Quality Assurance Specialist in Seoul, South Korea. Level rates it ; you can apply on Novartis.

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Level rates this role Little AI ●○○○: aI is not part of the work.
Level classifies it as a mid-level role.
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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

How we rate this

Quality Assurance Specialist at Novartis rates 37 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.