Compliance Engineer

Posted 8 Days Ago
Be an Early Applicant
Gurabo, PRI
In-Office
Senior level
Pharmaceutical
The Role
As a Compliance Engineer, you will manage compliance activities, revise documentation, and execute CAPAs in the pharmaceutical industry, ensuring adherence to GMP standards.
Summary Generated by Built In

For Compliance, Engineering and Quality Services.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s degree in Engineering and over five (5+) years of exposure in the Compliance and Quality activities within the Pharmaceutical industry.
  • Bilingual, Spanish and English.
  • Shift: Administrative and according to business needs.  
  • Experience in:
    • Manage investigations and CAPA from the Project Execution team and Site Engineering team as required.
    • Monitor GMP metrics such as Training, Change control on time closure,CAPA on time closure.
    • Revise documents in TV and Kneat.
    • Conduct GMP review of documentation.

The Personality Part:    

  • Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

  • Write, evaluate, and revise the required manufacturing documentation (SOP’s, MBR’s, etc.) and assist in providing training on scientific or technical aspects of the processes.
  • Responsible for executing Corrective Action Preventive Action (CAPA’s), procedures development & revision, and process validation documentation.
  • Act as facilitator for the necessary information related to the support of the existing processes and the fast tracking for documenting and implementing process modifications.

BEING A FITS PIECE COMES WITH PERKS:

  • One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out! 

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?

Skills Required

  • Bachelor's degree in Engineering
  • Over five years of exposure in Compliance and Quality activities
  • Bilingual, Spanish and English
Am I A Good Fit?
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The Company
HQ: Guaynabo, PR
76 Employees
Year Founded: 2008

What We Do

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]

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