GMP Professionals:  Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries, is seeking pharmaceutical GMP professionals to add to its growing cadre of per diem consultants.

Qualifications / Responsibilities include:

• Current understanding of FDA compliance trends and application of regulatory compliance principles
• Clear understanding of compliance with US regulations and guidance and ability to directly apply skill sets
• Manufacturing operations oversight including areas such as cleaning, maintenance, and validation
• Batch documentation reviews
• Verification of procedural and safety compliance
• Standard Operating Procedure development / reviews
• Equipment and processes troubleshooting
• GMP audits; GMP training
• Ability to evaluate validation programs for compliance to applicable regulations and standards
• Ability to analyze data across sources to identify quality signals
• Ability to solve problems in quality, including management of non-conformances, deviations and CAPA
• Ability to offer detailed, practical, and compliant solutions to identified quality system and regulatory gaps
• Knowledge of cleanroom GMP protocols
• Aseptic / sterile experience a plus
• Ability to solve problems using innovative techniques
• Excellent written and oral communication skills
• Excellent interpersonal and soft skills
• Willingness to work nights and weekends, as required
• Willingness to travel, sometimes on short notice

Educational requirements include:

• B.S. life sciences or engineering and 5 years’ related experience.