QUALITY ASSURANCE:
- Responsible for the final release of products in the absence of Sr. RA/QA Manager.
- Responsible for ensuring that all third-party suppliers comply with GMP and RGDI Quality Standards
- Supervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality-related policies in order to meet product quality standards.
- Review Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and sanitation activities.
- Audit quality control of raw materials, packaging components, labels, and finished products to ensure compliance with established specifications and regulatory standards.
- Follow up with implemented programs (GMPs, Good Hygiene Practices, Cleaning and Sanitation, Pest Control, Equipment Calibration) to ensure compliance by all employees and other personnel in the repacking facility.
- Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.
- Participate in all regulatory, third party and customer audits and inspections, and corrective action response.
- Perform other duties as directed by the RA/QA Department management.
- Maintain compliant and non-conformance processing through records and tracking systems, including root-cause analysis and corrective actions.
- Document quality assurance activities with internal reporting and audits.
REGULATORY AFFAIRS:
DOCUMENTATION
- Prepares and check submissions of License to Operate renewal and other inter-related regulatory correspondence with FDA.
- Timely monitoring of product, license, permit and other licenses for renewal and ensure that all FDA license, certificates, and permits are updated and valid.
- Reviews Standard Operating Procedure based on the actual activity.
- Ensures that all pertinent documents for Cosmetic are available for FDA inspection.
- Compiles and maintain complete technical data of each product by timely update of LTO’s master file
- Prepares, compiles, and maintains up-to-date Product Information Files (PIF) in compliance with ASEAN Cosmetic Directive requirements and ensures their availability during audits or regulatory inspections.
OPERATIONS
- Ensures that formulation conforms to FDA standards and is within the approved limit.
- Ensures that labels of new and existing items conform to ACD Standards.
- Checking of e-Portal for newly approved CPNs. Download, file and update the Notifications Summary.
- Generates barcode and monitoring of registration on-line.
- Ensures that RGDI warehouses are complying with FDA requirements.
- Assists FDA inspector with the needs during inspection and makes sure that company is compliant.
- Conducts product tests for all finished goods distributed and imported by the company.
- Maintain current knowledge of relevant regulations in Cosmetic and keeping up to date with changes in regulatory legislation and guidelines.
- Assists in updating related departments and regulatory head on latest regulatory requirements and FDA advisories.
- Coordinates the schedule of pest control in Marilao.
SUPPLIERS
- Monitoring in conducting annual audits of all active suppliers.
- Coordination with manufacturers for Product Information File for filing based on ASEAN Cosmetic Directive.
- Processing of initial and renewal of agreements and request for updated GMP and ISO of all active suppliers.
Qualifications:
- Graduate of Bachelor’s Degree in Pharmacy and a licensed Pharmacist.
- At least one (1) year work related experience in regulatory and/or QA field.
- At least 1 year of experience in a supervisory or team lead role.
- Familiarity with Philippine FDA processes, portals, and documentation.
- Strong understanding of local and international regulations on cosmetics and wellness products.
Job Type: Full-time
Benefits:
- Company events
- Employee discount
- Opportunities for promotion
- Promotion to permanent employee
Education:
- Bachelor's (Preferred)
License/Certification:
- PRC License (Preferred)
Work Location: In person