Team Lead QA

Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures

Major accountabilities:

• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
• Support exception investigations
• Review and approval of production, QC, and AS and T records
• MBR review
• Support OpEx improvement projects Qualified Person
• Executes batch release in compliance with registration
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt

Key performance indicators:

• On-time and GMP-compliant release of dosage forms -No Complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand.
• Successfully Support continuous improvement Projects -Executes batch release in compliance with registration

Minimum Requirements:

• Bachelor's degree is required;
• 6+ years of relevant QA
• Professional level of English and Spanish both written & spoken
• Excellent interpersonal & influencing skills with proven ability to build strong relationships
• Highly motivated self-starter with a willingness to assume responsibility & challenge the status quo
• Ability to work well under pressure and manage multiple tasks
• High competencies in stakeholder management

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation:

Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis tiene el compromiso de trabajar y proporcionar adaptaciones razonables para personas con discapacidad. Si, debido a una condición médica o discapacidad, necesita una adaptación razonable para cualquier parte del proceso de contratación, o para desempeñar las funciones esenciales de un puesto, envíe un correo electrónico a y permítanos conocer la naturaleza de su solicitud y su información de contacto. Incluya el número de posición en su mensaje.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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Division

Operations

Business Unit

Quality

Location

Mexico

Site

INSURGENTES

Company / Legal Entity

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.