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(this posting is closed/inactive)
Senior Pharmaceutical GMP Consultant
West Bloomfield, MI 48322 United States
Pay will be commensurate with experience and ability. This is a high-level position.
We are a U.S.-based company, however much of our work is for European locations. Our assignments will require international travel.
International Pharmaceutical consulting company is looking for a senior-level consultant to provide a wide variety of consultation services related to Pharmaceutical manufacturing operations. This is a subcontracted position.
Our company provides consulting services to Pharmaceutical manufacturers with a primary focus on cGMP and FDA regulatory compliance. We work with all dosage forms, and both API and finished product manufacturers, however we have particular expertise in aseptic operations. Our services are on a very high level, often working with our clients’ Executive Boards. Although we are a small company, we work with many of the world’s largest Pharmaceutical companies.
Help our clients by keeping abreast of the latest cGMP and regulatory compliance trends and enforcement priorities through reading, contacts and appropriate attendance at workshops.
Help our clients develop overall quality audit plans.
Perform on-site cGMP audits of our clients’ manufacturing facilities.
Help our clients with regulatory contact and coordinate responses to regulatory inquiries.
Oversee our clients’ GMP training programs to ensure regulatory compliance and promote continuous improvement.
Help draft and review SOP’s to ensure that they reflect current practices and are in agreement with regulatory requirements.
Review and comment on engineering drawings.
Assist on-site to coordinate facility start-ups, renovations, and validation programs.
Providing leadership and technical management for our clients’ Quality Assurance engineering functions.
Help to conduct failure investigations.
Provide guidance for our clients’ change control systems.
The Ideal Candidate will Meet the Following
15+ years of industry experience working in a pharmaceutical manufacturing environment.
M.S or Ph.D. in Chemistry, Engineering, Life Sciences or related.
Management experience in a pharmaceutical Quality Assurance setting.
Extensive knowledge of FDA and EMEA regulations.
Extensive experience in an aseptic processing setting.
A solid knowledge of quality control systems, engineering, aseptic design and philosophy.
Solid knowledge of critical utility systems such as purified water, water for injection, pure steam, and compressed gases.
Knowledge of the design and maintenance of specialized HVAC systems.
Knowledge of environmental monitoring and control systems.
Experience in auditing and FDA inspections.
Working knowledge of chemical and pharmaceutical manufacturing.
Working knowledge of Microbiology Laboratory methods.
Experience with Validation Master Plans.
Knowledge of statistical analysis.
Must have knowledge and understanding of applicable global regulations and GMP compendial requirements.Ability for extensive international travel on short notice.
Ability to work with international cultures on a global team.
Foreign languages helpful but not essential.
If you are qualified and would like to be considered, please submit your resume and cover letter. All inquiries and responses will be kept in strict confidence.
Education, training, experience:
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