Manager, Compliance

For Compliance services in the Quality area.

 WHAT MAKES YOU A FIT:  

The Technical Part:

• Bachelor’s Degree in Chemical, Engineering, Biology or Microbiology Science & five (5) years of exposure in Pharmaceutical Manufacturing industry. 
• Bilingual (English & Spanish)
• Experience in:
  • GMP, FDA, EU regulations
  • Technical Writing 
  • Investigation reports and regulatory and internal audits 
  • Computer Systems & Track wise

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)

• Acknowledge conduct and/or approve investigations for Customer Complaints, External Complaints, approve Regulatory CAPA, Vendor Certification, Quality Agreements, APR for Finished Product and Systems and site licenses.
• 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.
• Conduct internal / external audits following annual site plan with respective reports and actions items from areas impacted during the audit.
• Ensure the site has an internal audit program and that all system audits are conducted at a specified frequency.
• Create, review approves and track corrective actions related to internal and external audits and prepare, submit and discuss reports of assigned Quality Systems status for trending and evaluation to the site management.
• Provide site GMP training based on annual requirements and support and training to other departments to ensure quality compliance as needed.
• Generate, review and implement departmental procedure and forms to assure compliance with current practices or GMP’s trends.
• Ensure that Quality and Compliance is implemented in laboratory and operational areas and maintains it according with regulatory agencies expectations.
• Manage document including record retention program, compliance and custody of SOP’s, and review / approval / issuance of master documentation related to operational areas and evaluate compliance of all procedure (SOP’s) and master documentation with regulations and company policies.
• Provide guidance and support on the transfer and introduction of new products and processes to the site to maintain quality and compliance.

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?