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Aseptic Processing Auditor

2 months ago

Conshohocken, Pennsylvania, United States PharmaLex Full time

JOIN OUR CONSULTANT NETWORK
PharmaLex is a prominent and expanding consulting firm dedicated to the Healthcare sector.

We are currently experiencing a surge in demand for experts in Contamination Control Auditing, 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, creativity, enthusiasm, and hard work.

We are on the lookout for 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, pharmaceutical Quality Operations, QA Validations, or QA Auditing.
Familiarity with EU Annex 1, FDA Aseptic Processing Guidelines, and Quality Systems requirements supporting Bio/Pharma/ATMP product manufacturing is essential.
Understanding of Contamination Control Strategy and EU Annex 1 CCS requirements is required.
Knowledge of validation requirements that ensure sterility assurance for Bio/Pharma/ATMP products is crucial.
Strong familiarity with EU and US cGMPs and their relevance to manufacturing operations in a biologics context is preferred.
Direct 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.
Previous Quality Leadership oversight in Bio/Pharma/ATMP product manufacturing is beneficial.


To join the PharmaLex network for this and similar projects, candidates must demonstrate the following Core skills: Proficient technical writing and verbal communication skills in English and/or Spanish.

Advanced regulatory knowledge gained through experience in the pharmaceutical industry is essential.
Direct experience in a Bio/Pharma/ATMP manufacturing site or CMO is advantageous.
Ability to collaborate across functional areas or previous client engagement experience, such as with a CMO or similar entity, is a plus.
PharmaLex is an Equal Opportunity Employer.

We uphold equal opportunity employment practices, 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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