Pharmaceutical GMP QA Specialist

Pharmaceutical GMP QA Specialist

Synergy is seeking a detail-oriented and experienced Pharmaceutical GMP QA Specialist to ensure compliance with Good Manufacturing Practices (GMP) in pharmaceutical development and testing processes. The QA Specialist will be responsible for implementing and maintaining quality management systems, conducting inspections and audits, reviewing documentation, and ensuring all activities adhere to regulatory standards, including FDA, DEA, and ISO 17025 requirements. This role requires close collaboration with the development and testing teams to maintain compliance with the regulatory requirements.

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.
• Coordinate 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.

Education & Experience:

• Bachelor’s degree in Chemistry or Microbiology.
• Minimum 10 years of experience in pharmaceutical quality assurance with strong knowledge of GMP regulations.
• Experience working within the FDA, DEA, and ISO 17025.
• Proven ability to conduct audits and manage quality documentation.
• Strong communication, analytical, and interpersonal skills.

Requirements

Education:

• Bachelor’s degree in Chemistry or Microbiology.

Experience:

• 10 + years of experience in pharmaceutical quality assurance or GMP compliance.
• Familiarity with the FDA, DEA, and the 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