Job description

Job Responsibilities

1. Participate in creation/revamp of processes/programs and their implementation to ensure site is in full compliance with global/local regulations.

2. Collaborate with cross-functional groups such as quality control, operations, and facilities to:

a. Perform general documentation control and issuance (worksheet, logbook, notebook, and work order issuance)

b. Participate, monitor and track Deviations, OOS investigation and CAPA implementation

c. Support operations (line clearance, AQL inspection, label issuance)

d. Participate in Aseptic Process Simulations and Product manufacturing

e. Perform line clearance of production areas

f. Perform quality assurance review of applicable documentation

3. Participate in internal audit program and on-site regulatory audits

4. 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 2+ years relevant experience in the pharmaceutical industry

· In addition, 3+ years experience in pharmaceutical industry QA

· Experience in internal auditing

· Experience in external auditing and aseptic processing is preferred

· Firm knowledge of cGMPs and GDPs

· Be able to work efficiently and handle multiple tasks simultaneously

· Excellent communication skills (both oral and written)

· Work hard and be a team player

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

Job Type: Full-time

Pay: $50,000.00 - $100,000.00 per year

Benefits:

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

Schedule:

• Monday to Friday

Work Location: One location

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