Operations Process Compliance Specialist Job FITS LLC Humacaoby admin on more than 30 days
FITS LLC Job Vacancies 2020Description :
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!
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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 :
- Application will be treated strictly confidential .
- Only shortlisted candidate will be proceed on the next step.
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