Provide operations with the appropriate service and advice to assure that site quality systems are in place for regulatory compliance. Incumbent must assure that quality systems and programs such as internal audits, annual product reviews, stability, procedures, change controls, gap analysis, complaints, and other are in compliance with GMP regulations.
1. Responsible for assures the site quality systems are in place to avoid any possible regulatory compliance situation at the Site Manages the different quality systems and programs established at the site such as but not limited to Change Control, Packaging change controls, Stability, Policies and Directives, Regulatory CMC, Internal Audits, and others handled by the Compliance areas as assigned.
2. Prepares Annual Product Quality Reviews report for each pharmaceutical finished packaged and bulk drug products manufactured at the Site as per established timelines.
3. Reviews and prepares regulatory documentation intended for government regulatory agencies
4. Reviews, evaluates and approves plant operating documents such as SOPs, change control, qualification reports, CAPA, and process deviations to assure regulatory compliance.
5. Provides assistance in managing all aspects of regulatory and corporate inspections and participates actively during inspections and audits including performing readiness exercises before and during inspections and audits.
Five (5) years of experience in the pharmaceutical industry for oral dosage manufacturing
Fully bilingual (Spanish/English)
Solid technical writing and interpretation skills related to investigations, process & equipment validations and qualifications, computer system validations, Regulatory Filings, and customer complaints
Ability to create and organize cGMP systems and procedures based on regulatory compliance requirements
Knowledge on root cause analysis and investigation process
Quality Certifications is a plus
Quality Supplier agreements experience
BS degree (Engineering, Pharmacy, Chemistry, Biology).
Ultimate Solutions Corp is an Equal Opportunity Employer