Careers in Conventional and Complex Injectables

Job Description:

Position Summary

The Compliance Specialist is responsible for supporting quality and regulatory compliance within a GMP pharmaceutical manufacturing environment. This role reviews quality documentation, investigations, and audit trails, participates in internal and regulatory audits, and collaborates with cross-functional teams to ensure compliance with cGMP, GDP, and company procedures while promoting continuous quality improvement.

Job Responsibilities

• Collaborate with cross-functional groups such as quality control, operations, and facilities to thorough review accuracy and completeness of data generated to ensure overall compliance.
• Review audit trials for all the lab as well as manufacturing instruments.
• Perform initial investigation for any NOE, deviations, OOS.
• Keep track of on-going investigations, escalate to management as necessary. 
• Review investigation reports and ensure true root-cause has been identified and appropriate CAPA is initiated, to avoid recurrence.
• Participate in Aseptic Process Simulations and Product manufacturing to ensure compliance.
• Perform quality assurance review of documentations, protocol, reports, as necessary.
• Participate in internal audit program and on-site regulatory audits
• Provide interpretation/clarification to internal teams on regulations, guidelines, and SOPs.

Requirements

• Degree in chemistry, biology, engineering or other scientific discipline or related field, or 10+ years relevant experience in the pharmaceutical industry
• In addition, 3+ years of experience in pharmaceutical industry QA
• Experience in internal auditing
• Experience in external auditing and aseptic processing is preferred
• Firm knowledge of cGMP and GDP.
• Be able to work efficiently and handle multiple tasks simultaneously
• Excellent communication skills (both oral and written)
• Work hard and be a team player

**Please note this position is not eligible for employment visa sponsorship now or in the future

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

ForDoz Pharma Corp. is a specialty pharmaceutical company focusing on development, manufacturing, and commercialization of complex generic products (e.g. oncology and antifungal products) and improved existing products 505(b)(2). ForDoz Pharma Corp. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristics.