The SOQ Associate will be responsible for supporting, maintaining, and implementing the Quality Management System (QMS) at the Pfizer Country Offices (PCOs) to ensure compliance with both Pfizer and Regulatory Authority expectations.

The SOQ Associate will work closely with relevant local stakeholders, such as Global Regulatory Sciences (GRS), Global Supply Chain (GSC), Medical, and PGS sites or ESOQ to ensure that the appropriate quality standards and systems are implemented and maintained for the product supply operation of the Pfizer Korea business.

1. Quality Assurance & Inspections and Internal Audit

• Contributes to ensuring the timely implementation of applicable quality management systems (SOPs) within the PCO.
• Contributes to ensuring that initial and continuous training programs are implemented and maintained for all relevant PCO colleagues.
• Ensures planned, permanent & temporary changes of GMP/GDP related activities & systems are managed & documented appropriately.  Ensures change actions are completed as per agreed timelines.
• Collects key quality performance indicators, evaluates and highlights any significant trends and identifies actions.  Participates in Quality Review Meetings.
• Provides support in the preparation and coordination of any Health Authority (HA) inspection and/or internal Pfizer audits of GMP/GSP activities in the PCO.
• Work with local cross functional team to define appropriate action plans to address the inspection/audit observation and ensures action implementation within the agreed timelines.
• Participates in the self-inspection program, as required.
• Participates in the Quality Risk Management program for the consistent application, documentation and communication of risks to product quality/patient safety in support of GxP activities under the remit of SOQ.

2. Local Product Disposition & Resolution of Product Quality

• Execute the local release process for Products under the PCOs distribution licence.
• Supports the coordination of all Product repackaging and/or relabelling activities in the PCO and at the third-party packaging site.  Review & approve documentation related to the repackaging and/or relabelling of Pfizer Product.
• Actions Quarantine Alert Notifications promptly, as required.
• Ensures quarantine shipments are managed compliantly according to procedures, as required.
• Provides support for any market action operation in the PCO, as required.
• Complaint Handling – Perform Intake, issue correspondence letter as required.  Acts as a contact point/SME for reporter in the PCO.
• Identifies and investigates quality deviations and works with cross-functional teams to implement CAPAs.
• Notify Management of significant concerns or deviations within the QMS which have the potential to impact product, regardless of release status.  Where issues originate in the PCO, assist with the preparation of QRT meetings, where required.  Assist with the implementation of local actions identified during QRT.
• Management of relevant corrective and preventative actions (CAPA)

3. Supplier Quality Management

• Assist with the management of GMP/GDP vendors including qualification, quality oversight in accordance with internal and regulatory requirements for GMP/GDP activities.
• Assists with ensuring appropriate customer screening processes are in place to align with Pfizer and local regulations, as required.
• Assist with the coordination RQA audits at the vendor.

4. Leadership Skills

• Facilitate development and execution of objectives / projects consistent with SOQ Purpose Blueprint.
• Development and Maintenance of Quality culture, within the team and organisation.

5. KCMC Management

• Lead, plan and develop consensus with the relevant functions to set up submission time of the registration documents 
• Responsibility of KCMC preparing and translation of Specification and test method (STM)
• Communicate with and response to GCMC efficiently
• Work in close collaboration with QC to verify the translated STM
• Ensure completion of KCMC along with the registration schedule 
• Share the information and address issue timely manner with the stakeholders
• Response MFDS inquires related to quality and KCMC.

KEY PERFORMANCE INDICATORS (KPI)

List the more general result areas in which results (output) of the job can be measured.

• Works according to relevant SOP / WI
• SIR deviations, Regulatory Commitments, CAPA, CR, Complaints: monitored by KPI, VM, QRM and Supplementary metrics.
• Change Management: implemented by closing SOQ change requests and avoiding overdue requests.
• Vendor Managements: improved by completing action items and avoiding overdue items.
• Internal/ External Inspections: passed by avoiding critical or repeat findings.

QUALIFICATIONS

List the technical skills and knowledge. These will be the minimum entry requirements and necessarily know how for the job.

• Level of Education

A minimum Tertiary Education in Science, Pharmacy or related discipline.

• Experience

A minimum of 3 years in the pharmaceutical industry in a quality role

Demonstrated ability to influence, when necessary, particularly with stakeholders and external parties.

Experience in GMP, GDP, GLP, GSP and QMS.

Technical writing and reporting

• Languages

Fluent in English (written & verbal)

Fluent in Korean (written & verbal)

• Computer skills

Experience in Quality administered systems.

Excellent computer system skills – Word and Excel essential.

Experience with electronic documentation control systems advantageous.

Previous use of Trackwise®, eQMS beneficial.

COMPETENCIES – PERSONAL CAPABILITIES

Identify specific personal capabilities necessary to lead to outstanding performance in the job.

• Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy.
• GMP/GDP Knowledge. Trained and experienced in the total application of GMP/GDP.
• Auditing. Knowledge of Auditing procedures.
• Technical writing. Ability to lead a technical investigation and report to all levels of organisation.  Ability to write well-structured technical reports.
• Problem solving. Ability to use problem solving skills and tools to identify and eliminate problems as they arise.
• Takes initiative and ownership to deliver on time without compromising on quality.
• Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
• Acts Decisively. Makes decisions in a timely manner, makes good decisions based upon a mixture of analysis, experience, and judgment.  Able to demonstrate good planning and Organisation.
• Dealing with Ambiguity. Can effectively cope with change; shift gears comfortably; can decide and act without having the total picture; isn’t upset when things are up in the air; doesn’t have to finish things before moving on; can comfortably handle risk and uncertainty.
• Emotional Intelligence. Identify, assess and control the emotions of oneself and awareness of others.
• Takes Responsibility. Takes personal ownership of responsibilities and outcomes while following through on commitments

Application Deadline: 28th, March,2025.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

#LI-PFE