Quality Assurance Officer

Private Advertiser; Muntinlupa; Presencial; PHP 500.000 - 800.000; Jornada completa

Descripción de la vacante

Private Advertiser is seeking a Quality Assurance Officer to support pharmaceutical quality processes and document control. You will ensure compliance with GMP, GLP, and regulatory standards, while coordinating between QA, laboratory, and operations teams to maintain robust quality systems.

The role requires a Bachelor's in a scientific field and at least three years in a pharmaceutical lab with QA exposure.

Formación

• Bachelor’s degree in a scientific discipline such as pharmacy, chemistry, or biology.
• Minimum of three years in a pharmaceutical laboratory testing environment with QA experience preferred.
• Understanding of GMP, GLP, ISO standards, USP/EP quality documentation requirements.

Responsabilidades

• Perform preliminary checks of SOPs, records, reports, and other QA documents for completeness, plausibility, accuracy, and missing information.
• Liaise with laboratory and internal teams to resolve documentation gaps and follow up on required corrections.
• Maintain QA records covering deviations, change controls, CAPA, corrective actions, audits, inspections, and supplier management.
• Create, revise, and coordinate approvals for SOPs and quality documents in Track Wise Digital.
• Monitor document review deadlines and retraining requirements.
• Review raw data from equipment qualification and re-qualification for completeness and compliance with SOPs and GMP requirements.
• Assist with equipment qualifications and validation activities, change controls, and deviations.
• Support computerized systems validation activities and periodic system audit trail reviews.
• Follow regulatory updates and initiate change controls with references and impact rationales.
• Coordinate subcontractor qualification and status records.
• Support internal and external audits and regulatory inspections.

Conocimientos

QA documentation

Regulatory compliance

Communication skills

Cross-functional collaboration

Attention to detail

Educación

Bachelor's degree in a scientific discipline such as pharmacy, chemistry, or biology

Herramientas

Track Wise Digital

Labvantage LIMS

Microsoft Office

Excel

Descripción del empleo

About the role

Join the GBS team as a Quality Assurance Officer supporting pharmaceutical quality processes, documentation, equipment qualification, regulatory compliance, and audit readiness. You will work closely with laboratory, QA, operational, and subcontractor teams to maintain robust quality systems and ensure assigned activities are completed accurately and on time.

Key responsibilities

• Perform preliminary checks of SOPs, records, reports, and other QA documents for completeness, plausibility, accuracy, and missing information.

• Liaise with laboratory and internal teams to resolve documentation gaps and follow up on required corrections.

• Gather, organise, and maintain QA records covering deviations, change controls, CAPA, effectiveness checks, change assessments, complaints, audits, inspections, training, quality reviews, and supplier management.

• Create, revise, maintain, and coordinate approvals for SOPs and other quality documents in Track Wise Digital.

• Track document review deadlines, training assignments, completion status, and retraining requirements.

• Review raw data from equipment qualification and re-qualification activities for completeness, accuracy, and compliance with applicable SOPs and GMP requirements.

• Assist with equipment qualifications, qualification status monitoring, equipment-related change controls and deviations, inventory management, and raw data administration.

• Support Computerised Systems Validation activities, analytical software administration, and periodic system audit trail reviews.

• Monitor updates to applicable regulations, pharmacopoeias, and guidance documents, and initiate relevant change controls with documented references and impact rationales.

• Follow up with change control owners to support timely assessment and closure, escalating foreseeable delays when required.

• Coordinate subcontractor qualification activities and maintain qualification status records.

• Support internal and external audits and regulatory inspections.

• Complete assigned activities within agreed timelines and comply with applicable quality, QHSE, HR, integrity, and professional conduct policies.

What we’re looking for

• Bachelor's degree in a scientific discipline such as pharmacy, chemistry, or biology.

• At least three years of experience in a pharmaceutical laboratory testing environment, with QA experience strongly preferred.

• Understanding of laboratory processes, analytical equipment, EU and U.S. GMP regulations, and quality documentation requirements.

• Knowledge of GLP, ISO standards, USP, and EP is advantageous.

• Proficiency in Microsoft Office applications, including Outlook, Word, and Excel, with the ability to learn new technologies quickly.

• Strong written and verbal communication skills in English, including the ability to produce clear, regulatory-compliant documentation.

• Experience with Track Wise Digital or a comparable quality management system is preferred.

• Experience with Labvantage LIMS or an equivalent laboratory information management system is advantageous.

• Reliable, structured, self-organised, and detail-oriented working style with the ability to identify discrepancies.

• Ability to manage multiple tasks, prioritise effectively, meet deadlines, and collaborate across laboratory, QA, and operational teams.

• Proactive approach to regulatory monitoring and follow-up, with a strong commitment to data integrity, confidentiality, compliance, and continuous development.