Top 8 pharmaceutical solid dosage consultant Jobs

EU Generalist
Lachman Consultant Services —Remote
- Per diem
- Bachelor of Science
- Writing skills
- Bachelor's degree
Former Health Agency Experts
Lachman Consultant Services —Remote
- Full-time
- Bachelor of Science
- Bachelor's degree
- Senior level
Sr. Analytical Scientist
Two95 International Inc. —Durham, NC
- Contract
- Bachelor of Science
- Analysis skills
- Bachelor's degree
Quick Apply
Process Development Consultants
Pharmatech Associates —San Francisco, CA
- Remote
- 11+ years
- English
- Master's degree
Staff Scientist, Pharmaceutical Development
Septerna —San Francisco, CA
- $160,000 - $180,000 a year
- Bachelor of Science
- 11+ years
- Bachelor's degree
Senior Project Manager (Validation)
Novo Nordisk —Clayton, NC
- Computer literacy
- Engineering
- Office
- Paid holidays
- Disability insurance

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EU Generalist

Lachman Consultant Services -
Remote

Apply Now

Job Details

Per diem

Qualifications

Foreign language proficiency
Writing skills
Bachelor's degree

Full Job Description

EU Pharmaceutical / Biopharmaceutical Experts: 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 consultants on a per diem basis who are proficient in both the English and one other European language (reading, writing, and speaking) who live in the European Union This includes compliance, regulatory, and/or scientific/technical professionals, including former senior-level MHRA, EMA, and regulatory officials and staff, with demonstrable hands-on experience and skill in one or more of the following areas:

Qualifications / Responsibilities include:

Various dosage forms including oral solid, liquid, and other non-sterile, as well as sterile, dosage forms
Demonstrated regulatory compliance expertise as it relates to the testing of drug products and/or active pharmaceutical ingredients
Pre-approval and post-market FDA inspections; Post-market reviews, considerations, safety reporting, regulations and guidances; Pre-marketing requirements, activities, regulations and guidances
Pre-approval and pre-license inspection programs and compliance evaluations for ANDA, NDAs, and BLAs
Experience in performing GMP / GLP audits covering laboratory procedures and practices for Quality Control Laboratories; GMPs / GLPs / guidances and regulations; Laboratory QA
Data integrity requirements; electronic data reviews
GMPs for packaging, storage, and distribution of products
FDA 483, Warning Letter, Consent Decree remediation of complex matters
Remediation of laboratory control systems
Laboratory investigations including OOS and mitigation, deviations, and change control records
Quality Systems / Quality Assurance / Quality Control / Quality Standards
Regulatory filings
Drug review and approval process
Process validation
OOS investigations and change control
Supply chain controls
SOP and documentation practices; SOP development and reviews
Facilities and Equipment
Risk assessment process / application
Computer Systems validation
Microbiology
Training
Regulatory Affairs Experience (experience with DMF’s and ANDA’s for generic APIs and drug products is preferable)
Ability to lead projects and meet crucial timelines / project management
Superb written and oral communication skills
Excellent interpersonal and soft skills
Ability to solve problems using innovative techniques

Educational / Experience Requirements include:

Consultants must read, write and speak / effectively communicate in English and one other European language. Strong communication / presentation skills, verbal and written, and the ability to recognize and differentiate importance of issues and prioritize accordingly.
B.S. life sciences, engineering or related field, and 10 years’ related experience, and detailed knowledge of current FDA regulations and expectations.

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Refine Your Search

pharmaceutical solid dosage consultant jobs

EU Generalist

Former Health Agency Experts

Sr. Analytical Scientist

Process Development Consultants

Staff Scientist, Pharmaceutical Development

Senior Project Manager (Validation)

Other jobs to consider

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