QA Senior Specialist - Environmental Monitoring

Set up as a new job alert
15788en
  1. Contract
  2. English
  3. Mid-Senior level
  4. Legal, Regulatory & Compliance
  5. Switzerland
  6. Healthcare & Life Sciences

Skills

Microbiology, GMP, QA, GC, FDA, EMA, Written & Oral Communication Skills,

Click here to get a notification every time a job like this gets added

Great news! We will let you know when a new job like this has been added!

This vacancy has now expired
On behalf of our client, a multinational manufacturing company for the pharmaceutical, biotechnology and nutrition sectors, we are looking for a QA Senior Specialist to provide Quality oversight for the qualification (environmental monitoring PQ) of manufacturing facilities and PQ of clean utilities systems.

Start Date: 1st of April
Location: Visp
Work type: On site
Workload: 100%
Duration: 8 months
Extension: Possible

Your Mission:
- Ensure facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participate in developing action plans
- Analyze and interpret environmental monitoring data, identify trends, and implement adequate corrective actions.
- Collaborate with cross-functional teams to ensure contamination prevention and control requirements are met for new product introductions, facility adaptations, and process
changes
- Lead and guide Investigations of monitoring excursions, contamination incidents, and deviations from contamination control procedures
- Provide microbiological expertise to support Investigations, CAPAs, and Change Control related to Contamination Prevention and Control
- Develop and deliver training programs to facility staff on contamination prevention and control, Cleanroom behavior, and hygiene best practices
- Supports regulatory inspections and customer audits as a Pharmaceutical Microbiology subject matter expert

Your background:
- Bachelor's degree in a relevant scientific discipline (preferably in microbiology)
- GMP experience in the biologics industry, with direct QA or directly relevant QC Microbiology experience
- Strong knowledge of contamination control principles, practices, and regulations (e.g., FDA, EMA)
- Working knowledge of microbiological testing methods, media challenges, environmental monitoring, clean room qualification and management, and microbiological control
strategy required
- Excellent written and oral communication to include accurate and legible documentation skills
- Strong sense of ownership and the ability to prioritize based on business needs is necessary
- Fluency in English, ability to communicate in or willing to learn German

What’s an offer?
You get to work in a dynamic environment in a company that really values it’s employees.

Apply now by submitting your resume here or sending it directly to veronika.nakev@swisslinx.com

What is FMCG?

READ MORE

Top Emerging Technologies: Trends to Watch Out for in 2024

READ MORE