Pharmaceutical GMP QA Specialist

Key Responsibilities

• Ensure adherence to pharmaceutical GMP regulations and internal quality standards.
• Conduct routine and for-cause internal audits and inspections of chemistry, microbiology, and molecular biology laboratories.
• Review and approve GMP-related documentation, including test results, technical reports, investigation reports, and SOPs.
• Cook up with cross-functional teams to address non-conformities and implement corrective and preventive actions (CAPAs).
• Support regulatory inspections and manage responses to audit findings.
• Monitor quality metrics and report on compliance status.
• Provide training and guidance on GMP requirements to laboratory personnel.

Requirements

• Education: Bachelor’s degree in Chemistry or Microbiology.
• Experience: Minimum 10 years of experience in pharmaceutical quality assurance with strong knowledge of GMP regulations.
• Familiarity with the FDA, DEA, and ISO 17025 regulations and requirements.
• Experience in conducting audits and managing quality systems.

Skills

• Strong analytical and problem-solving abilities.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively in cross-functional teams.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Training & Development