GMP Compliance & Quality Assurance Lead

Square Pharmaceutical, Inc; Carmona; On-site; PHP 600,000 - 1,000,000; Full time

Job summary

Square Pharmaceutical, Inc is seeking a Compliance/QA professional in the Philippines to strengthen our Pharmaceutical Quality System and ensure adherence to PIC/S GMP, WHO, and regulatory requirements.

You will lead CAPA activities, perform risk assessments, review critical documents, train staff, and collaborate with Production, QC, QA, Engineering, and Warehouse to maintain consistent quality across departments.

Qualifications

• Bachelor's Degree in Pharmacy, BS Chem Eng, BS Chemistry, or BS Biology.
• Experience in Quality Assurance, FDA Compliance/GMP Compliance, Good Documentation Practices.
• Good comprehension and technical writing skills.
• Good communication across departments.
• Proactive approach.

Responsibilities

• Facilitate Annual Self Inspection and monitor closure/effectiveness of every department CAPA.
• Address Self Inspection and External audit findings by preparing, implementing and monitoring closure of CAPA.
• Prepare, review, and update Compliance Unit procedures to comply with local and international regulatory requirements.
• Prepare Risk Assessment related to Compliance.
• Review and approve controlled documents such as SOPs, batch manufacturing records, validation reports, and deviation reports.
• Monitor change control, Deviation Report, CAPA, Non Conformances, and ensure documentation are updated accordingly.
• Participate in product complaint, product recall management and investigation processes.
• Support validation and qualification activities (equipment, processes, and utilities).
• Conduct compliance and GMP training programs for all personnel.
• Collaborate with Production, QC, QA, Engineering, and Warehouse departments to ensure consistent compliance to standards and requirements of the Pharmaceutical Quality System, PIC/S GMP, WHO and Regulatory agency

Skills

Quality Assurance

FDA Compliance

GMP Compliance

Good Documentation Practices

Technical Writing

Cross-functional Communication

Proactive Approach

Education

Bachelor's Degree in Pharmacy

BS Chem Eng

BS Chemistry

BS Biology

Job description

Square Pharmaceutical, Inc is seeking a Compliance/QA professional in the Philippines to strengthen our Pharmaceutical Quality System and ensure adherence to PIC/S GMP, WHO, and regulatory requirements.

You will lead CAPA activities, perform risk assessments, review critical documents, train staff, and collaborate with Production, QC, QA, Engineering, and Warehouse to maintain consistent quality across departments.