**Summary**:
Supports effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators). -Supports the preparation and management of external and corporate audits and Health Authority inspections
**About the Role**:
**Major accountabilities**:
- Planning and supporting PQR/APQR activities
- Support site qualification and validation activities (planning, advising, review)
- Implementation of Quality Systems (incl. documentation management) -Supplier management activities (agreements, oversight, audit)
- Preparation/support and coordination of CAPA/follow-up
- Audit and inspection preparation and support
- Change control review/approval -Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.)
- Ensure process quality assurance acc.
- to regulations ,QP declaration review and approval,
**Key performance indicators**:
- Ensures planning and successfully supports PQR/APQR activities
- Successfully carries out site qualification and validation activities (planning, advising, review)
- Supports the implementation of Quality Systems (incl.



documentation management);
- Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc)
- Ensure process quality assurance according to regulations
**Minimum Requirements**:
**Work Experience**:
- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
- cleanliness zones.
- Functional Breadth
**Skills**:
- Action Oriented.
- Continuous Learning.
- Dealing With Ambiguity.
- Functional Skills.
- Gmp Procedures.
- Process Optimization.
- Qa (Quality Assurance).
- Quality Standards.
- Self Awareness.
- Technological Expertise.
- Technological Intelligence.
- GxP.
- Industry standards.
- Compliance requirements.
**Languages**:
- English.
Division
Operations
Business Unit
Innovative Medicines
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
**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

📌 Document Management Specialist (Baja California Sur)
🏢 Novartis
📍 Baja California Sur