For Investigation services in the Quality area
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's or Master's degree in Science (Degree or master in chemical, Engineering, Biology or Microbiology) & five (5) years of exposure in the Pharmaceutical industry.
Experience in:
Strong Knowledge of relevant GMP, FDA, EU regulations.
Fully Bilingual (Spanish/ English) communication skills, both written and verbal ae required.
Expert in the interpretation and applications of regulations according with the intended use.
The Personality Part:
Working under pressure, while exercising good judgement seems like a tough thing to pull off, but we know you're a pro at this already. Add to this 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)
Acknowledge, review and/or approve site investigations and CAPAs including their correlated Corrective Actions and Preventive Actions (CAPA).
Maintain communication with internal & external customers to ensure compliance & timely completion of investigations activities.
Review investigations related to process, products, utilities, microbiology laboratory and calibrations.
Support readiness of the facility for Regulatory Inspection.
Assist the Associate Director Compliance and auditing during regulatory agencies inspections such as FDA / EMEA and/or during internal company audits.
Documents any FDA communication between Site and agency.
Prepare, submit and discuss reports of assigned Quality Systems status for trending and evaluation to the site management.
Assure that site complies with Corporate Systems by evaluating, implementing and enforcing the company policies and guidelines.
Manage documents including record retention program, compliance and custody of SOP's, and review / approval / issuance of master documentation related to operational areas and; evaluates compliance of all procedure (SOP's) and master documentation with regulations and Policies.
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?
TSZsvSprOW
