工作重点
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 China business.
工作摘要 - 主要职责领域/职责
1
Quality Assurance & Inspections and Internal Audit
- Contributes to ensuring the timely implementation of applicable quality management systems processes, global and local procedures, work instructions, Job Aid and controlled documents within the PCO.
- Participates in assessing new quality system/local regulatory requirements and adjust/enhance local systems and processes when required.
- 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/GDP 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 license.
- Supports the coordination of all Product repackaging and/or relabeling activities in the PCO and at the third-party packaging site. Review & approve documentation related to the repackaging and/or relabeling of Pfizer Product.
- Actions Quarantine Alert Notifications promptly, as required.
- Ensures quarantine shipments are managed compliantly according to procedures, 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) and QAP actions
- As CICR manager, where required, handles physical record management
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 organization.
5
Local Requirements
- Support to establish and update supplier quality files, sales customer quality files and product quality files under PCO distribution license.
- Responsible for the collection, feedback and processing of drug regulation and quality information.
- Assist for supervising and documenting the destruction process of non-conformity drugs.
- Assist for archiving market action /mock recall records.
- Assist quality management involving external business contacts including LSP quality issues handling.
- Responsible to collect and archive for department documentation.
- Assist as needed for IDC importation testing/surveillance testing.
- Assist Annual Product Report/Annual Product Quality Review Report completion as need for regulation requirements.
- Assist other required from local regulations.
关键绩效指标 （KPI）
- Works according to relevant SOP / WI
- SIR deviations, Regulatory Commitments, CAPA, CR, QAP, 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.
资格
A minimum Tertiary Education in Science, Pharmacy or related discipline
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, GSP and QMS.
Technical writing and reporting.
Licensed Pharmacist is preferred
Fluent in English (written & verbal)
Experience in Quality administered systems.
Excellent computer system skills – Word and Excel essential.
Experience with electronic documentation control systems advantageous.
Previous use of, eQMS beneficial.
竞争力 – 个人能力
- 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 organization. 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 Organization.
- 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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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Quality Assurance and Control
