Compliance Assurance Manager

hace 2 semanas

Manatí, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

**Company Overview**

Flexible & Integrated Technical Services, LLC is a service provider company that integrates 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.

**Job Description**

We are seeking a Compliance Assurance Manager to join our team. In this role, you will be responsible for ensuring that our site has an internal audit program and that all system audits are conducted at a specified frequency. You will also create, review, approve 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.

**Key Responsibilities**
  • 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.

**Required Skills and Qualifications**

To be successful in this role, you will need:

  • Bachelor's Degree in Chemical, Engineering, Biology or Microbiology Science.
  • Five 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.

**Benefits**

We offer a competitive salary and benefits package, including:

  • Flexible working hours.
  • Opportunities for career growth and development.
  • A supportive and inclusive work environment.

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