QA Specialist - 7079

CTC Resourcing Solutions; Basel; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions is partnering with a global pharmaceutical company in Basel to hire a QA Specialist for Investigational Medicinal Products (IMPs).

You will review GMP documentation and batch records, support QA release activities, manage eDMS like Veeva Vault, and coordinate with CMOs to resolve quality topics, while tracking deviations and changes. Ideal candidates have 1–3 years in GMP QA environments and a Life Sciences degree.

Qualifikationen

• Bachelor's degree in Life Sciences, Pharmacy, or a related field.

Aufgaben

• Review GMP documentation and executed batch records for completeness and compliance.
• Support QA release activities for Investigational Medicinal Products (IMPs).
• Identify, document, and escalate discrepancies and quality issues.
• Prepare and maintain batch documentation packages.
• Manage QA documentation within electronic document management systems (eDMS), including Veeva Vault.
• Maintain accurate QA-related records and batch information in ERP systems such as SAP.
• Track deviations, change controls, complaints, temperature excursions, and other quality events.
• Perform initial reviews of investigations received from CMOs.
• Coordinate with internal stakeholders and external manufacturing partners to ensure timely resolution of quality topics.
• Support the maintenance and review of Quality Agreements with CMOs.
• Collect and consolidate CMO quality metrics and contribute to KPI and trend reporting.
• Ensure QA documentation remains accurate, complete, and inspection-ready.

Kenntnisse

GMP/GDP principles

Organizational skills

Time management

Attention to detail

Problem solving

English communication skills

German and/or French

Ausbildung

Bachelor’s degree in Life Sciences, Pharmacy, or a related field

Tools

Veeva Vault

SAP

Jobbeschreibung

Our client, a global pharmaceutical company, is looking for a QA Specialist to support Quality Assurance activities related to Investigational Medicinal Products (IMPs).

The role focuses on GMP documentation review, quality system activities, batch documentation, and coordination with Contract Manufacturing Organizations (CMOs). The successful candidate will contribute to ensuring that QA operations remain compliant, timely, and inspection-ready.

Key Responsibilities

• Review GMP documentation and executed batch records for completeness and compliance.
• Support QA release activities for Investigational Medicinal Products (IMPs).
• Identify, document, and escalat discrepancies and quality issues.
• Prepare and maintain batch documentation packages.
• Manage QA documentation within electronic document management systems (eDMS), including Veeva Vault.
• Maintain accurate QA-related records and batch information in ERP systems such as SAP.
• Track deviations, change controls, complaints, temperature excursions, and other quality events.
• Perform initial reviews of investigations received from CMOs.
• Coordinate with internal stakeholders and external manufacturing partners to ensure timely resolution of quality topics.
• Support the maintenance and review of Quality Agreements with CMOs.
• Collect and consolidate CMO quality metrics and contribute to KPI and trend reporting.
• Ensure QA documentation remains accurate, complete, and inspection-ready.

Required Skills & Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
• 1–3 years of experience in QA, QC, pharmaceutical manufacturing, or a similar GMP environment.
• Good practical knowledge of GMP/GDP principles.
• Experience reviewing GMP documentation such as batch records, deviations, and change controls.
• Strong organizational and time-management skills, with the ability to manage multiple priorities.
• High attention to detail and a structured, process-oriented approach.
• Ability to identify quality issues, propose solutions, and escalat appropriately.
• Strong written and verbal English communication skills.
• German and/or French would be an advantage.