Contamination Control (Annex 1) Auditor

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PharmaLex is a highly successful and growing consulting company for the Healthcare industry. Recently, we are receiving increase in demand for Contamination Control Auditors and our goal is to grow our consultant pool to prepare for these exciting and upcoming projects. We are committed in providing career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.
We are seeking experienced consultants who are expert on Annex 1 Gap Assessment Projects:
Work Arrangements: ONSITE
Duration: Approximately 3-5 days gap assessment & 1-2 weeks of report writing (total of 90+ hours in 2-3 weeks)
A successful candidate to perform this project in the US must possess the following Technical skills:

• Bachelor’s degree (or higher) in Microbiology and 10+ years of relevant experience in commercial aseptic processing pharmaceutical Quality Operations, QA Validations or QA Auditing
• Working knowledge of EU Annex 1, FDA Aseptic Processing Guideline and Quality Systems requirements supporting Bio/Pharma/ATMP product manufacturing
• Knowledge of Contamination Control Strategy and EU Annex 1 CCS requirements
• Working knowledge of validation requirements supporting sterility assurance of Bio/Pharma/ATMP products
• Strong knowledge of EU and US cGMPs and applicability to manufacturing operations in a biologics environment is preferred.
• Direct experience leading root cause analysis or sterility assurance investigations is a plus.
• Minimum 3 years auditing experience for aseptic processing facilities manufacturing Bio/Pharma/ATMP products; certified quality auditor is a plus.
• Previous Quality Leadership oversight for Bio/Pharma/ATMP product manufacturing is a plus.

A successful candidate to join the PharmaLex network for this and similar projects must possess the following Core skills:

• Demonstrated technical writing & speaking fluency in English and/or Spanish.
• Advanced regulatory knowledge acquired through experience in the pharma industry.
• Direct experience in a Bio/Pharma/ATMP manufacturing site or CMO is a plus.
• Ability to work across functional areas, or previous client engagement experience, such as CMO or similar is a plus.

PharmaLex is an Equal Opportunity Employer.