QA Specialist (7079)

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

Zusammenfassung

CTC Resourcing Solutions is seeking a QA Specialist to support GMP documentation review, QA activities for IMPs, and coordination with CMOs. The role focuses on ensuring documentation completeness, inspection readiness, and timely QA operations.

The ideal candidate will have a Life Sciences/Pharmacy degree and 1–3 years of GMP experience, with strong attention to detail and English communication skills; German or French would be an advantage.

Qualifikationen

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
• 1–3 years of experience in QA, QC, pharmaceutical manufacturing, or a GMP environment.
• Knowledge of GMP/GDP principles.
• Experience reviewing GMP documentation (batch records, deviations, change controls).
• Strong organizational and time-management skills.

Aufgaben

• Review GMP documentation and executed batch records for completeness and compliance.
• Support QA release activities for Investigational Medicinal Products (IMPs).
• Prepare and maintain batch documentation packages.
• Manage QA documentation within eDMS, including Veeva Vault.
• Maintain QA-related records and batch info in SAP.
• Track deviations, change controls, complaints, and temperature excursions.
• Perform initial reviews of investigations from CMOs.
• Coordinate with internal and external partners to resolve quality topics.
• Support maintenance and review of Quality Agreements with CMOs.
• Consolidate CMO quality metrics and contribute to KPI reporting.
• Ensure QA documentation remains accurate and inspection-ready.

Kenntnisse

GMP/GDP principles

English communication

Quality documentation review

Time management

Attention to detail

Ausbildung

Bachelor's degree in Life Sciences/Pharmacy or related

Tools

Veeva Vault

SAP

Jobbeschreibung

QA Specialist – 7079

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 esc ... ???
• 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 escal... ???
• Strong written and verbal English communication skills.
• German and/or French would be an advantage.