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Contamination Control Risk Assessment

1 month ago

Conshohocken PA United States PharmaLex GmbH Full time

JOIN OUR CONSULTANT NETWORK

PharmaLex is a highly successful and growing consulting company for the Healthcare industry. Recently, we are receiving increase in demand for Contamination Control Consultants 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 Contamination Control Risk Assessment & Strategy Projects:
Work Arrangements : Either ONSITE or REMOTE.
Duration: Approximately 100+ hours in a span of 3-4 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 or QA Validations.
  • Working knowledge of ICH Q9 and EU Annex 1 as applies to microbial risk assessments.
  • Formal training and hands-on experience with FMEA and quantitative risk analysis methods is required.
  • Direct experience with 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.
  • Experience in cell and gene therapy and/or Rapid Micro Methods (RMM) is a plus.
  • Direct experience leading root cause analysis or sterility assurance investigations is a plus.

A successful candidate to join the PharmaLex network for this and similar projects must possess the following Core skills:
  • Demonstrated writing & speaking fluency in English and/orSpanish.
  • 3+ years previous people management experience facilitating a team.
  • Advanced regulatory knowledge acquired through experience in the pharma industry.
  • Direct experience in a pharmaceutical manufacturing site.
  • Ability to work across functional areas, or previous client engagement experience, such as CMO or similar.
  • Demonstrated ability to facilitate and coach a team, PMP certification a plus.
  • Strong analytical reasoning skills and lateral thinking across functions.

PharmaLex is an Equal Opportunity Employer.

We are an equal opportunity employer and all qualified applicants will 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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