Quality Assurance Associate

Celltrion Inc; Taguig; On-site; PHP 600,000 - 900,000; Full time

Job summary

Celltrion Inc in the Philippines is seeking an experienced QA professional to support pharmacovigilance QA activities, CAPA management, and audit readiness within a fast-paced pharmaceutical environment.

The role emphasizes training record upkeep, deviation tracking, QMS compliance, and cross-functional collaboration with PV Operations to ensure accurate documentation and regulatory readiness.

Strong attention to detail, English fluency, and familiarity with eQMS/LMS are required to succeed.

Qualifications

• Minimum 3 years in QA with PV experience, including 1 year in PV QA.
• Fluent in English with strong communication skills.
• Proficient with QA documentation practices and record-keeping.
• Experience with software tools for training management and document control.
• Knowledge of GxP/GVP requirements and regulatory expectations.

Responsibilities

• Support QA workflows in training assignments, QMS updates, deviation and CAPA tracking and follow-up.
• Maintain accurate training records and monitor training completion within the Learning Management System (LMS).
• Assist in preparing documentation for audits and inspections, ensuring all records are complete, accurate, and audit‑ready.
• Perform quality checks on documents and data to ensure accuracy, compliance, and proper version control.
• Collaborate with PV Operations and other cross‑functional teams to gather information, resolve documentation needs, and support compliance activities.
• Issue deviations and CAPAs, and monitor notifications received from the QMS.
• Support deviation owners in identifying root causes, assessing impact on pharmacovigilance activities, and determining whether a CAPA is required.
• Track, classify, evaluate, and review deviations, deviation investigations, and CAPA plans.
• Report deviations to the appropriate deviation and/or CAPA owner as needed.
• Update the Deviation/CAPA Log and verify completion evidence prior to closure.
• Seek review and approval from the QA Team Lead or designee for deviation and CAPA documentation.
• Contribute to continuous improvement initiatives related to deviation and CAPA processes.
• Assist in preparing documentation and logs for internal audits, external audits, and regulatory inspections.
• Retrieve training records, procedural documents, and other quality evidence as requested.
• Actively participate in QA meetings and provide updates to the QA Team Lead.

Skills

Pharmacovigilance

Quality Assurance

Documentation control

LMS proficiency

GxP knowledge

Root cause investigation

Team collaboration

Attention to detail

English fluency

Tools

eQMS

LMS

DMS

GxP systems

Job description

• Support QA workflows in training assignments, QMS updates, deviation and CAPA tracking and follow‑up.
• Maintain accurate training records and monitor training completion within the Learning Management System (LMS).
• Assist in preparing documentation for audits and inspections, ensuring all records are complete, accurate, and audit‑ready.
• Perform quality checks on documents and data to ensure accuracy, compliance, and proper version control.
• Collaborate with PV Operations and other cross‑functional teams to gather information, resolve documentation needs, and support compliance activities.

Corrective and Preventive Action (CAPA) Management

• Issue deviations and CAPAs, and monitor notifications received from the QMS.
• Support deviation owners in identifying root causes, assessing impact on pharmacovigilance activities, and determining whether a CAPA is required.
• Track, classify, evaluate, and review deviations, deviation investigations, and CAPA plans.
• Report deviations to the appropriate deviation and/or CAPA owner as needed.
• Update the Deviation/CAPA Log and verify completion evidence prior to closure.
• Seek review and approval from the QA Team Lead or designee for deviation and CAPA documentation.
• Contribute to continuous improvement initiatives related to deviation and CAPA processes.

Audit and Inspection Support

• Assist in preparing documentation and logs for internal audits, external audits, and regulatory inspections.
• Retrieve training records, procedural documents, and other quality evidence as requested.
• Support the QA team in tracking and responding to auditor/inspector requests.

Team and Administrative Responsibilities

• Actively participate in QA meetings and contribute relevant updates or insights.
• Provide the QA Trackers and other required reports to the QA Team Lead or designee.
• Complete tasks assigned by the QA Team Lead in a timely and compliant manner.

General

• A total professional work experience of at least 3 years including 2 years’ experience in pharmacovigilance of which at least 1 year in pharmacovigilance Quality Assurance
• Fluent in English; Knowledge in additional language(s) is an advantage.
• Excellent organizational and prioritization skills.
• Ability to work in a fast‑paced pharmaceutical environment needed.
• Ability to work collaboratively and effectively in a team environment.
• Experience with computer applications including database management,
• Quality Management System, Good Documentation Practices, and Root Cause Investigation
• Basic understanding of GxP/GVP requirements and quality documentation practices preferred. Familiarity with quality systems (eQMS, LMS, DMS) is an advantage.
• Strong attention to detail, organizational skills, and willingness to learn.