Frederick, MD, USA
10 hours ago
PLS Senior Consultant

Job Description: We are seeking an experienced GLP and GCLP Consultant to join our dynamic team. The ideal candidate will have a strong background in regulatory compliance within the pharmaceutical, biotechnology, or related industries. As a GLP and GCLP Consultant, you will provide strategic advice and hands-on support to ensure our clients' laboratory operations meet or exceed regulatory requirements.

Key Responsibilities:

Conduct comprehensive audits of laboratory processes and facilities to ensure compliance with GLP and GCLP regulations. Develop and implement GLP and GCLP training programs for laboratory staff. Advise clients on the design and execution of GLP and GCLP-compliant studies. Prepare and review GLP and GCLP documentation, including standard operating procedures (SOPs) and study protocols. Assist in the preparation for regulatory inspections and audits. Stay up-to-date with changes in GLP and GCLP regulations and industry best practices. Provide ongoing support and guidance to clients to maintain GLP and GCLP compliance.

Qualifications:

Bachelor’s degree in a scientific discipline; advanced degree preferred. Minimum of 15 years of experience in a GLP and GCLP-compliant environment. In-depth knowledge of GLP and GCLP regulations and industry standards. Excellent analytical, problem-solving, and communication skills. Ability to work independently and as part of a team. Strong organizational skills and attention to detail.
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