You manage quality assurance and compliance tasks, oversee supplier relationships, and prepare for audits while ensuring adherence to regulations and maintaining effective communication with health authorities.
Anforderungen
- •University education in natural sciences
- •At least 3 years experience in QA
- •Knowledge of GMP required
- •Preferably experience in negotiations
- •Fluent knowledge of English and German
- •Flexibility to work in a fast-paced environment
- •Ability to operate in a global matrix
Deine Aufgaben
- •Manage suppliers, technical service providers, and contractors.
- •Establish and oversee Quality Assurance Agreements.
- •Prepare for audits and inspections.
- •Coordinate self-inspections and manage internal audits.
- •Implement and manage Quality Systems and documentation.
- •Support CAPA coordination and risk assessments.
- •Report and trend KPIs and KQIs.
- •Review and approve change controls.
- •Ensure local deviation management and process quality assurance.
- •Plan and support PQR/APQR activities.
- •Maintain applications and certificates for local HA.
- •Facilitate communication with health authorities and stakeholders.
Deine Vorteile
Incentive program
Company pension scheme
Childcare facilities
Learning opportunities
Worldwide career possibilities
Original Beschreibung
# QA Compliance Expert
**Schaftenau** | **Full time**
**Band**
Level 4
**Job Description Summary**
QA Compliance Expert is responsible for managing cost 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). Performs preparation and management of external and corporate audits and Health Authority inspections.
**Job Description**
**Major accountabilities:**
* Supplier, technical service provider and contractor management/qualification (quality agreements, oversight, audit, medical device) including planning and surveillance of audit plans
* Establishment, maintenance and oversight of Quality Assurance Agreements affecting Drug Product Schaftenau (medical device); Audit and inspection preparation and support
* Ensure supplier-, contractor- and internal/HA/customer management in 1QEM as audit coordinator, preparation and performance of self-inspections
* Implementation of Quality Systems (incl. documentation management)
* Preparation/support and coordination of CAPA/follow-up and alert-/gap-/risk assessments; KPI / KQI reporting and trending
* Change control review/approval; ensure local deviation management; ensure process quality assurance acc. to regulations and supports local project-/regulatory management and Site Master File preparation
* Planning and supporting PQR/APQR activities; ensure applications, certificate maintenance etc. to local HA
* Support communication with HA, GCA / One voice / consolidated approach / synergies for all sites within same HA jurisdiction / country
**Minimum Requirements:**
* University education in natural sciences, chemistry, biology or similar
* At least 3 years or more experience in QA Experience in operations management and execution
* Knowledge of GMP required
* Preferably experience in negotiations and global collaboration
* Fluent knowledge of English and German language (written and spoken)
* Flexibility to work in a fast paced, quickly changing work environment
* Ability to operate in a global matrix environment
**Skills Desired**
Auditing, Audit Management, Communication Skills, Compliance Audits, Compliance Risk, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gmp Procedures, Inspection Readiness, Organizational Skills, People Management and Leadership, Qa (Quality Assurance), Regulatory Compliance, Risk Management, Self-Awareness, Technological Expertise