Company Pharmacist/Document Controller

AS A COMPANY PHARMACIST/QUALIFIED PERSON:

● Ensure pharmaceutical activities comply with applicable Philippine FDA requirements, GMP, and company policies and procedures.

● Provide pharmaceutical and regulatory oversight of manufacturing, storage, quality control, and distribution activities, as applicable.

● Review and ensure the completeness, accuracy, and compliance of pharmaceutical, quality, and regulatory documents.

● Prepare, maintain, and support the submission of regulatory documents for product registration, variations, renewals, licenses, and other FDA requirements.

● Coordinate with QA, QC, Production, Warehouse, Regulatory Affairs, and other departments on pharmaceutical and regulatory compliance matters.

● Review and support the management of deviations, change controls, CAPA, investigations, complaints, recalls, and other quality-related activities.

● Participate in GMP audits, self-inspections, regulatory inspections, and inspection-readiness activities.

● Ensure required pharmaceutical and quality records are properly completed, reviewed, maintained, and readily retrievable.

● Perform the required review and authorization for the release of finished products in accordance with approved specifications, GMP requirements, and company procedures.

● Maintain current knowledge of Philippine FDA regulations, GMP requirements, and applicable pharmaceutical standards.

● Perform other duties related to the Company Pharmacist/Qualified Person function as assigned by Management or the immediate supervisor.

AS A DOCUMENT CONTROLLER:

● Establish and maintain an effective document and records control system in accordance with the company QMS and applicable GMP requirements.

● Maintain the Document Master List and ensure proper document numbering, identification, revision, and traceability.

● Control the preparation, review, approval, issuance, distribution, revision, retrieval, and archiving of controlled documents.

● Ensure only current and approved versions of SOPs, policies, procedures, forms, specifications, protocols, and other controlled documents are available at points of use.

● Review documents for completeness, proper formatting, signatures, dates, revision history, and required approvals prior to issuance.

● Ensure obsolete or superseded documents are promptly withdrawn, identified, archived, or disposed of in accordance with established procedures.

● Maintain secure and organized filing systems for controlled documents, quality records, and regulatory documents, including electronic records where applicable.

● Coordinate periodic document review and monitor overdue revisions with concerned departments.

● Ensure timely retrieval and availability of required documents and records during audits, inspections, and regulatory activities.

● Report document control deficiencies, missing records, unauthorized document use, and other documentation concerns to the QA Head or immediate supervisor.

● Maintain confidentiality and security of controlled documents and quality records.

● Perform other Document Control-related duties as assigned by Management or the immediate supervisor.

Pay: Php22,000.00 - Php25,000.00 per month

Work Location: In person