QA Senior Specialist - Environmental Monitoring

☞ headcount | recruitment driven by scientists

見る: 121

更新日: 29-03-2024

場所: Visp Valais VS

カテゴリー: 品質保証/品質管理

業界: Pharmaceutical Manufacturing

ジョブタイプ: Contract

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仕事内容

Location: Visp

Start: ASAP

Duration: 9 months

Workload: Full-time

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

The main objective of this position is to provide quality oversight, ensure compliance with regulations, and lead initiatives related to contamination prevention and control in manufacturing facilities and clean utilities systems within the biologics industry, utilizing microbiological expertise to analyze data, implement corrective actions, and support regulatory inspections and audits.

Your Tasks

Providing Quality oversight for the qualification (environmental monitoring PQ) of manufacturing facilities and PQ of clean utilities systems.

Ensuring facility and quality systems state of compliance with internal requirements and appropriate regulations.

Participating in development of action plans to correct deficiencies and ensure adequate microbiological quality of the site facilities, utilities, processes and products.

Analyzing and interpreting environmental monitoring data, identifying trends, and implementing adequate corrective actions.

Collaborating with cross-functional teams to ensure contamination prevention and control requirements are met for new product introductions, facility adaptations, and process changes.

Leading and guiding investigations of monitoring excursions, contamination incidents, and deviations from contamination control procedures.

Providing microbiological expertise to support Investigations, CAPAs, and Change Control related to Contamination Prevention and Control.

Developing and delivering training programs to facility staff on contamination, prevention and control, clean room behavior, and hygiene best practices.

Supporting regulatory inspections and customer audits as a Pharmaceutical Microbiology subject matter expert.

Your Profile

Bachelor’s degree in a relevant scientific discipline (preferably in microbiology).

Substantial 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.

Fluency in English, ability to communicate in or willingness to learn German.

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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締切: 13-05-2024

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