Compliance Specialist - Qc Compliance

Descripción del Empleo:
Conducts investigations for Customer Complaints, External Complaints, approve Regulatory Corrective Actions and Preventive Actions (CAPA), Vendor Certification, Quality Agreements, Annual Product Review/Report for Finished Product and Systems and site licenses.
2. Supports readiness of the facility for Regulatory Inspection. Assists 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.
3. Conducts internal / external audits following annual site plan with respective reports and actions items from areas impacted during the audit. Ensures 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.
Requisitos:
Bachelor Degree in Chemical, Engineering, Biology or Microbiology Science.
Five 5 years of experience in Quality Unit responsibilities in the pharmaceutical industry.
Fully Bilingual (Spanish/English) communication skills, both written and verbal are required.
Strong knowledge of relevant GMP, FDA, EU regulations.
Expert in the interpretation and application of regulations according with the intended use.
Self-motivated, creative and team work oriented.
Excellent interpersonal skills and the ability to interact with people at all levels.
Strong Technical Writing Skills to prepare trends analysis, investigation reports and regulatory and internal audits responses.
Self-motivated, creative and team work oriented.
Self starter and good organizing and planning skills
Excellent knowledge of computer systems (Microsoft Office, etc.) and tracking system