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8 months ago
Salary band: $10k - $15k
Location: North America, United States, Texas
Job type: Permanent
Contact: DisperSol Technologies, LLC
Category: Quality Engineer
Job Description

I. Essential Duties & Responsibilities

Manage the validation life cycle of company equipment and software

Manage validation of analytical testing methods

Process incoming equipment into the cleaning verification program

Manage process transfers and scale up activities

Assist in build out of product containment systems

Generate, Review, and Revise SOPs and other controlled documents as needed

Investigate production problems to determine root cause

Participate in CA/PA implementations

Develop and maintain quality metrics and measurements

Assist in troubleshooting in-house equipment issues

II. Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

Understand drug formulation, analytical method development, drug manufacturing practices

Complex problem solving and troubleshooting

Advanced decision making skills

Organizational skills required

Strong multi-tasking skills required

Pharmaceutical background preferred

III. Qualifications

Education

Bachelor's Degree in Engineering, or combination of education and experience in a related discipline

Experience

8-20 years in industry

GMP experience required

Experience using Risk Analysis in Process Validation preferred

Experience with 21 CFR Part 11 preferred

Communication Skills

Oral and Written Communication - Speaks and writes clearly and informatively

Computer Skills

Microsoft Office Suite

SharePoint

Ability to quickly learn new software packages


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