Job description summary
support for the preparation of documents such as (but not limited to) initial quality questionnaires (qq), quality assurance agreement (qaa), quality risk assessment (qra), annual monitoring report (amr), audit capa management (creation, monitoring, and closure), and audit request change form required for the quality management of suppliers. Additional responsibilities include employee training, compiling, analyzing, and reporting metrics and strategies to continuously improve processes.
job description
major accountabilities
* responsible for preparing documents throughout the complete lifecycle of a supplier, such as qq, qaa, and qra, in accordance with company, regulatory, internal, and external guidance.
* manage audit capa plan uploads and follow-up actions with suppliers.
* draft and submit audit request change forms.
* support risk experts in evaluating and completing third-party risk assessments for suppliers within defined timelines.
* write and update applicable sops.
* monitor kpis agreed with the customer for each deliverable.
* schedule meetings with the team or quality manager to determine and assign follow-up actions as needed.
* assist qa manager in reviewing documentation throughout the supplier lifecycle to ensure compliance with novartis requirements.
* communicate with internal stakeholders or third parties as required.
key performance indicators
* manage quality aspects and projects within the area.
* achieve applicable process kpis and kqis.
* ensure partner satisfaction and responsiveness.
* adhere to project timelines and proactively manage upcoming issues.
* generate and deliver reports related to owned activities.
* maintain compliance with cgmp, sops, and avoid critical deviations or findings.
work experience
at least 3 years in the pharmaceutical industry or a similar field. Solid experience in data analysis and reporting.
skills
* quality assurance
* continuous improvement
* good manufacturing practices
* local/international health regulations
* solution-oriented behavior
* self-organization
* stakeholder engagement
* effective communication
language
* english
* portuguese, according to needs
skills desired
continued learning, dealing with ambiguity, good documentation practice, guidelines, knowledge of capa, qa (quality assurance), quality management, regulation, self-awareness, technological expertise
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