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Senior QA/CSV Consultant (cGMP - Data Integrity) JD818711

JD818711

DPS is seeking an established and knowledgeable Senior Quality Consultant to support a BioPharma client in the Southern MA area. This individual will serve as the liaison between the Quality Control, Quality Assurance, Engineering, Supply Chain and Manufacturing teams in identifying key data integrity issues or concerns and addressing them as appropriate. This includes assisting in the assessment of all stand-alone instruments, local computerized and Enterprise computerized system software, creating remediation plans and execution. This role will be responsible for documenting all issues found with follow through of action plans to remediate.

Category:
Quality
Location:
Massachusetts
Years of Experience Req.:
5+
Date Posted:
01/10/2019
Days Remaining:
13
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior QA/CSV Consultant (cGMP - Data Integrity)                          JD818711

Southern MA area

 

DPS is seeking an established and knowledgeable Senior Quality Consultant to support a BioPharma client in the MA area. This individual will serve as the liaison between the Quality Control, Quality Assurance, Engineering, Supply Chain and Manufacturing teams in identifying key data integrity issues or concerns and addressing them as appropriate. This includes assisting in the assessment of all stand-alone instruments, local computeriz795618.4733ed and Enterprise computeriz795618.4733ed system software, creating remediation plans and execution. This role will be responsible for documenting all issues found with follow through of action plans to remediate.

 

Responsibilities:

  • Cross-departmental partnering to ensure integrity is maintained throughout the data lifecycle.
  • Identify data integrity issues and formulate strategies to address the issues and improve internal processes.
  • Is a subject matter expert in data integrity for maintaining high quality data and processes site-wide.
  • Initiate and review applicable change controls, quality incident investigations and CAPAs, tracking progress and following up to ensure requirements are met.
  • Identify and present opportunities for process improvements.

 

Qualifications & Experience:

  • Bachelor’s Degree in Science or related technical field.
  • 5+ years QA cGMP experience in a regulated pharmaceutical/biotechnology industry.
  • Working knowledge of current cGMP, GDP, and data integrity principles.
  • A thorough understanding of FDA, EMA and ICH quality regulations.
  • Ability to work with minimal supervision as well as in a team environment 
  • Strong organiz795618.4733ational and presentation skills.
  • Strong relationship, teambuilding, customer-focused orientation coupled with the ability to deliver results and meet or exceed agreed-upon objectives and timeframes.
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