Contamination Control Specialist
5 days ago
PharmaLex, a leading consulting company for the Healthcare industry, is seeking experienced consultants to join our network for Contamination Control Auditor projects. Our goal is to grow our consultant pool to prepare for increasing demand in this area.
We are committed to providing career opportunities in a collaborative atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. Our consultants will work on exciting projects, including Annex 1 Gap Assessment Projects, and will have the opportunity to develop their skills and expertise.
Key Responsibilities:
- Perform Contamination Control Auditor projects, including Annex 1 Gap Assessments
- Develop and implement Contamination Control Strategies
- Conduct root cause analysis and sterility assurance investigations
- Lead audits and provide quality assurance
Requirements:
- Bachelor's degree in Microbiology or related field and 10+ years of relevant experience
- Working knowledge of EU Annex 1, FDA Aseptic Processing Guideline, and Quality Systems requirements
- Strong knowledge of Contamination Control Strategy and EU Annex 1 CCS requirements
- Minimum 3 years auditing experience for aseptic processing facilities
What We Offer:
- Opportunity to work on exciting projects with a leading consulting company
- Collaborative and dynamic work environment
- Professional development and growth opportunities
PharmaLex is an Equal Opportunity Employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment.
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