Quality Assurance Analyst

hace 2 semanas

Insurgentes, México Novartis A tiempo completo

**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.

**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

BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

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