Quality Assurance Specialist

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 Life Sciences or related fields (Pharmacy preferred)

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