Operations Process Compliance Specialist Job FITS LLC Humacao

by admin on more than 30 days

FITS LLC Hiring 2020 - FITS LLC need a new official to apply Operations Process Compliance Specialist that will be placed in Humacao.

FITS LLC Job Vacancies 2020

Description :

For Process Compliance services in the Quality area

WHAT MAKES YOU A FIT:

The Technical Part:

  • Bachelor’s degree in Science, pharmacy and/or Engineering & five (5) years of exposure in a Oral Solid Dosage Manufacturing facility
  • Experience in:
    • Operational and scientific investigation
    • Computer applications (Microsoft Word, Excel, Power Point)
    • SOPs and CAPA’s
    • Manufacturing documentation

The Personality Part:

  • If you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!

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


  • Execute and ensure that all Quality Events (QEs) and CAPAs are completed / closed within the established timeframe, utilizing the right tools to measure effectiveness to prevent reoccurrence.
  • Review and provide input to regulatory submissions applicable to area of responsibility.
  • Interact with regulatory compliance agencies with respect to Quality Events.
  • Provide written responses to regulatory observations as well as ensuring implementation of commitments.
  • Conduct systematic QEs evaluations to minimize risk of reoccurrence and; ensures the effectiveness of CAPA’s.
  • Support establishment of process monitoring parameters and control limits
  • Manage Quality Council metrics (i.e. QE’s and CAPA’s) and share trends and gaps with management.
  • Evaluate and revise manufacturing documentation resulting from a compliance gap and; may assist in providing training related to the revised manufacturing documentation.
  • Participates and represents the manufacturing department in all process compliance initiatives including regulatory inspections.
  • Revise and update SOPs to ensure robustness in our operations to reduce/eliminate potential investigations

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?


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If you match the profile and are interested in this exiting career opportunity, please apply in confidence by filling online application form at :


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Notes :
  • Application will be treated strictly confidential .
  • Only shortlisted candidate will be proceed on the next step.

If you are not interested in Operations Process Compliance Specialist Humacao August 2020 FITS LLC above, you can try to find your job by read related jobs from another company in Humacao below.


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