QA Specialist

June 11, 2024

we are looking for...

QA Specialist

Contracting

Ref: BH-2033

QA Specialist

Job details

Contracting

Ref: BH-2033

Website headcount

QA Specialist 

Location: Visp
Start: ASAP
Duration: 3 months
Workload: Full-time

On behalf of our client, a Swiss multinational manufacturing company for the pharmaceutical industry, we are looking for a QA Specialist. 

The main objective of this position is to ensure the highest standards of quality and compliance within the company’s operations.

Key Responsibilities:

Your Tasks: 

  • Verifying compliance with ISO/cGMP quality system requirements, providing immediate support to operations and quality control staff to address compliance related concerns (QA “on-the-floor” support). 
  • Making independent quality-related decisions based on regulatory and compliance knowledge, providing independent quality support to project teams. 
  • Auditing internal quality system elements in manufacturing and operational support areas, providing oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations. 
  • Performing external audits of suppliers/vendors/off-site facilities and acting as a customer interface during on-site audits, conference calls and other standard means of communication. 
  • Identifying and managing special projects or QA compliance functions as agreed upon with QA management. Prioritize and manage a variety of projects simultaneously. 
  • Leading and directing the work of others. 
  • Reviewing and approving validation documents and Master Batch Records (MBR) and supporting documents. Perform review/release of batch records, as needed. 

Your Profile: 

  • 3-5 years of experience in QA for commercial drug substances/products, or equivalent experience in aseptic processing and cell therapy manufacturing.
  • Knowledge of PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1. 
  • GMP compliance and Part 11 compliance knowledge preferred.
  • Experience with oversight of aseptic processing and the associated international aseptic processing regulations. 

Please apply directly online with your CV.

**Please only apply if you are eligible to work in Switzerland and the EU**

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