Quality Assurance Auditor for Contamination Control
2 weeks ago
JOIN OUR CONSULTANT NETWORK
PharmaLex is a dynamic and expanding consulting firm dedicated to the Healthcare sector.
We are currently experiencing a surge in demand for specialists in Contamination Control Audits, and we aim to enhance our consultant network in anticipation of these promising projects.
Our commitment lies in offering career opportunities within an environment that prioritizes trust, respect, collaboration, innovative talent, enthusiasm, and hard work.
We are in search of seasoned consultants with expertise in Annex 1 Gap Assessment Projects:Work Arrangements :
ONSITE
Duration:
Approximately 3-5 days for gap assessment & 1-2 weeks for report writing (totaling over 90 hours within 2-3 weeks)
The ideal candidate for this project in the US should possess the following Technical skills: A Bachelor's degree (or higher) in Microbiology along with 10+ years of pertinent experience in commercial aseptic processing within pharmaceutical Quality Operations, QA Validations, or QA Auditing.
Familiarity with EU Annex 1, FDA Aseptic Processing Guidelines, and Quality Systems requirements that support Bio/Pharma/ATMP product manufacturing is essential.
Understanding of Contamination Control Strategy and EU Annex 1 CCS requirements is crucial.
Proficiency in validation requirements that ensure sterility assurance for Bio/Pharma/ATMP products is expected.
Strong knowledge of EU and US cGMPs and their relevance to manufacturing operations in a biologics context is preferred.
Experience in leading root cause analysis or sterility assurance investigations is advantageous.
A minimum of 3 years of auditing experience in aseptic processing facilities manufacturing Bio/Pharma/ATMP products is required; certification as a quality auditor is a plus.
Prior Quality Leadership oversight in Bio/Pharma/ATMP product manufacturing is beneficial.
To successfully join the PharmaLex network for this and similar initiatives, candidates must demonstrate the following Core skills: Proficient technical writing and verbal communication skills in English and/or Spanish.
Direct experience in a Bio/Pharma/ATMP manufacturing site or CMO is a plus.
Ability to collaborate across functional areas or previous client engagement experience, such as with a CMO or similar, is advantageous.
PharmaLex is an Equal Opportunity Employer.
We uphold equal opportunity employment principles, ensuring that all qualified applicants receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state, or local law.
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