Teva Pharmaceuticals USA, Inc.

Quality Analyst I Third Party Operations

US-PA-Horsham
Requisition #
17-20123
# Positions
1
Experience (Years)
1
Category
Quality - Quality Assurance

Overview

Teva's Third Party Operations Quality team is currently seeking a Quality Analyst I.

Responsibilities

Essential Duties & Responsibilities

  1. Review of batch documentation for product release including batch records, certificates of compliance, certificates of analysis, shipping documentation and temperature monitor reports.  
  2. Review investigations, change control and CAPA from 3rd party contractors. Coordinate internal/external resources to address GMP issues. Provide guidance on GMP issues arising in the development or commercialization of new products. 
  3. Must represent and participate in project team meetings/supply meetings TPO QA US. 
  4. Assist with critical quality/compliance issues to assure continued supply of commercial product to the market as well as meeting new product launch timelines.
  5. Audit Annual Product Reviews from 3rd party contractors and evaluate data within.
  6. Perform compliance review of process validation documentation from 3rd party contractors and approve final validation documentation for TPO QA US. 
  7. Remain current on all cGMPs, Teva operating procedures and Teva guidelines.  
  8. Follows Teva Safety, Health, and Environmental policies and procedures

Qualifications

 

Education Required:

 

B.S. in biology, biochemistry, chemistry microbiology or related science. or equivalent years of job experience.

   

Experience Required:

 

Minimum 1+years of experience with scientific background and solid understanding and knowledge of GMPs and Regulatory Guidelines. 

 

Experience Preferred:

 

Previous experience working in pharmaceuticals or GMP regulated industry. QA/QC experience a plus. Knowledge of Oracle, Trackwise and SAP preferred. Write SOPs, update SOPs and work instructions for Quality. 

 

Functional Knowledge:

 

Aseptic processing, sterility assurance, microbiology. Device, biologics and complaint knowledge a plus.

 

Company/Industry Related Knowledge:

 

cGMPS, CFR, ICH and EMEA

 

Job-specific Competencies

 

*  Specific knowledge of GMP good documentation practices.

*  Able to work effectively in a team environment as well as individually

*  Investigative and problem solving skills

*  Good presentation skills

*  Good communication and interpersonal skills.

 

Travel Requirement: Up to 10% 

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