Cross Contamination Experts

  • Anywhere
  • Posted 1 month ago

Lachman Consultants

Lachman Consultants is in need of Per Diem Consultants, who are experts in control, containment, and prevention of cross contamination of pharmaceutical drug products and APIs.  Must have demonstrable, hands-on experience that includes experience and skill in the following areas:

  • Expert in Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) / implementation of Risk-MaPP principles
  • Knowledge of FDA, EU, ICH Q9, and ISO regulatory requirements for sterile and non-sterile drug product, including antibiotics
  • Development, coordination, and implementation of onsite cross-contamination protection systems
  • Assessment and implementation of cross-contamination controls and risk assessment strategies
  • Environmental Monitoring Programs / Environmental control / testing of air quality
  • Facility design / HVAC systems to prevent cross-contamination
  • Equipment cleaning, maintenance, and validation practices
  • Production process as relates to cross contamination / transfer / sampling operations
  • Protocol studies for cross contamination data gathering
  • Quality Risk Management
  • Cross contamination risk assessments and risk management
  • Toxicological risk assessments
  • Use of Acceptable Daily Exposure (ADE) for managing risk of cross contamination
  • SOPs / training in cross contamination management

Consultants must have a minimum of a Bachelor’s degree in life sciences, engineering or related field and 10 years’ related experience, as well as detailed knowledge of current FDA regulations and expectations. Strong communication / presentation skills, verbal and written, and the ability to recognize and differentiate importance of safety issues and prioritize accordingly. If you meet all of the qualifications, please submit your full chronological resume via the Lachman website or to recruitment@lachmanconsultants.com. No phone calls please. Thank you.

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