Resolution of Product Quality Compliance Issues

Deviation Management:

Ensure any investigations, out-of-specifications, change controls, complaints and any other quality related matter throughout the production from all associated manufacturing sites is closed.

Execute review and ensure any associated deviation is managed and closed within Pfizer’s QMS

Ensure any changes that may require a variation to marketing authorization, manufacturing license or GMP clearance are notified to management as per Pfizer’s procedures.

Assist in writing Area-Quality Review Team (A-QRT/ SQRT) reports and participate in meetings.

Notification to Management

Informs SCMOQ China Lead Team of significant deviations, as well as any issues impacting marketed product.

local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions

Change Control management

Ensure all initiation of changes contains all the relevant information and attached documents(if any).

Coordination with initiator to open occurrence record in QTS.

Ensure all change implementations meet the requirements of the change process.

Quarantine Alert Notices (where non-Pfizer warehouses are used to receive and store product in the country)

Ensure that Quarantine Alert Notices received are processed in a timely manner.

Commitment Tracking

Ensure Regulatory, Internal Audit and deviation commitments are completed as required.

Market Actions

Support local market action team and ensure effective completion of all required actions.

Product Quality System

Confirm GSOP compliance, completion of gap analysis reports and training.

Monitor local quality performance (metrics) and identify and implement actions upon discovery of trends/issues and share with all relevant local stakeholders.

Assess any new or updated regulatory requirements and implement.

Participate in Continuous Improvement for processes and systems.

Complete the annual product report as per regulation required timeline.

Participate in imported product post-marketing change and communicate with ESOQ and manufacturing site if there are action items(such as CoA/CoC revise etc.) related to quality.

Product Disposition

Review Certificate of Analysis, COC, and any other relevant information, of fully finished products

Conduct transactions in Systems, Applications and Products (SAP)

Oversight of returned goods.

Ensure effective and efficient local batch release.

Assess temperature excursions, using available data or plant support and provide batch disposition.

Coordinate regular quality review meetings with the distribution warehouse quality unit.

Liaise with External Supply Operations Quality (ESOQ) and the manufacturing site to determine disposition of product which have experienced a temperature excursion.

Ensure that a system is in place to manage.

Ensure that records are made and maintained for inspections is undertaken in accordance with and assessed against appropriate specifications.

Implement appropriate batch disposal of returned and non-conforming products.

Complete pre-launch preparation and market release of new products

Inspections and Internal Audit

Lead preparation for and co-ordination of GSP/MAH agent related inspections by Regulatory Authorities or Pfizer internal auditors

Prepare and agree with SCMOQ manager and applicable colleagues on responses an action plans to address issues identified during regulatory inspections or Pfizer internal audits.

Track the implementation of the identified actions within agreed timeframes.

Local Contractor Quality Oversight

Ensure effective quality oversight of local contractors (Logistic Service Providers, re-packers)

Ensure quality agreements are maintained and reflect current requirements.

Review quality performance and agree action plans to ensure continuous improvement

Communicate critical and major regulatory inspection observations and RQA audit findings to SCMOQ China Lead Team and provide input into CAPA plans.

Provide Quality Due Diligence for local contractors and ensure CAPAs can be addressed and closed in a timely manner.

Product Complaint handling

Support domestic product manufacturer site to complete product quality complaint investigations.

Intake and triage where they classify the complaint and forward to site for investigation of its expedited.

Notification of Expedited Complaints to Local and Global Management colleagues.

Receipt and assessment of the complaint sample.

Forwarding of complaint to relevant plant or technical assessment of complaint.

Preparation of product complaint investigation package.

Tracking and follow up of investigation.

Technical evaluation of investigation data and report.

Follow up and review of corrective and/or preventative actions.

Escalate complaint trends to Management.

Training

Create SOP or other on-job training courses.

Establish Training Curriculum and assign training as required.

Prepare annual training plan and track the training proceed.

Complete assigned training

QUALIFICATIONS

Bachelor’s degree in pharmacy, Sciences or equivalent degree.

GSP/GDP Knowledge. Trained and experienced in GSP/GDP, carry out responsibilities independently for QA management judge and supervise for products quality and management.

IT systems. Experienced with Quality Systems.

Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy.

Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.

Good English communication skill.

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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