Pharmaceutical Aseptic Operations’ Consultants

  • Anywhere

Website Lachman Consultants

Lachman Consultants is seeking life sciences expert consultants with demonstrable skills in aseptic/sterile controls and assessments for pharmaceutical products and operations which include:

  • Aseptic cGMP manufacturing operations
  • Aseptic technical expertise
  • SOPs (development and mentoring)
  • Quality Assurance / Quality Systems specialist in laboratory and aseptic manufacturing operations
  • Training on proper aseptic techniques in manufacturing and the laboratory
  • Utilities – validation / qualification studies
  • Good / demonstrated remediation skills; including remediation of microbial contamination and sterility assurance matters
  • Laboratory test data reviews
  • OOS investigations (performance, mentoring and review)
  • Laboratory facilities auditing
  • Microbiology testing
  • Development of microbiology laboratory methods
  • GxP reviews; GAP analysis
  • Microbial Method validation review
  • Change Control (evaluation)
  • Environmental Monitoring activities
  • Process simulation (media fills) and smoke study review and evaluation
  • Cleaning activities as it pertains to aseptic processes

Consultants must have:

  • Minimum of a Bachelors’ degree in Microbiology or Biology w/coursework in microbiology and 10 years’ experience;
  • Detailed knowledge of current FDA/Global regulations and expectations;
  • Knowledge of current international standards and submission specifications;
  • Verifiable Microbiological familiarity;
  • Current “hands-on” pharmaceutical microbiological expertise in aseptic / sterile operations.

Candidates should also have strong communication / presentation skills, verbal and written, and the ability to recognize and differentiate the importance of issues and prioritize accordingly.

Apply to:  https://www.lachmanconsultants.com/jobs/

For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.

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