QA Manager

Vor 7 Tagen


Basel, Basel-Stadt, Schweiz ITech Consult AG Vollzeit

QA Manager - GMP / Quality Risk Management / Qualification / Validation/ Parenterals / English & German

Description:
The IMP Quality Operations Unit Switzerland in Global Technical Operations is the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland. They are responsible for the Quality, Quality Systems, and GMP compliance oversight of all Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies. The Clinical Supply Centre in Basel for Parenterals is responsible for manufacturing Sterile Drug Products for clinical studies. The candidate will support and drive the full implementation of Annex 1 in the role as Quality Assurance Manager, collaborating closely with all involved parties from the Clinical Supply Centre Parenterals.

The ideal candidate:
The perfect candidate has a strong background in Quality Assurance, Annex 1 implementation, sterile Drug Product Manufacturing, Qualification, Validation, and parenteral manufacturing activities.

Responsibilities:

- Support and drive implementation of Annex 1 requirements within the Clinical Supply Centre for sterile Drug Product (Parenterals)
- Represent Quality Assurance in all activities related to the implementation of Annex 1 within IMP Quality Operations Switzerland
- Maintain and support Qualification/Validation and parenteral manufacturing activities within IMP Quality Operation Switzerland
- Collaborate with Quality Assurance Managers within IMP Quality Operations Switzerland
- Provide technical expertise for review and approval of quality-related documents
- Partner with stakeholders to ensure successful delivery of Annex 1 implementation goals
- Support area of responsibility at HA inspections and internal audits

Requirements:

- BS/MS/PhD Degree in relevant fields
- 2-5 years experience in a GMP regulated environment with Quality Systems and Assurance
- Experience in Quality Risk Management, risk assessments, Qualification, Validation, and parenteral manufacturing
- Fluent in German and English B2
- Fast learner, team player with self-motivation and ability to prioritize tasks
- Proven ability to work independently and in a team
- Excellent planning and organizing skills with analytical and innovative problem-solving capabilities

Preferred qualifications:

- Experience with Annex 1
- Knowledge in Discrepancy Management, CAPA, Technical Change Management
- Project management skills
- Proficient in health authority inspections and internal GMP audits

Reference Nr.: 923408SDA
Role: QA Manager
Industry: Pharma
Location: Basel
Availability: 100%

Start Date: Immediate
Duration: 12++


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