7 days old

Supply Chain Quality Supervisor, China

Pfizer
Beijing
**POSITION RESPONSIBILITIES**



**1.Resolution of Product Quality Compliance Issues**



**1.1** **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



**1.2 Product Complaint handling**



+ 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 reports

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

+ Escalate complaint trends to Management



**2.Notification to Management**



+ Informs SCQ Greater China Cluster Lead of significant deviations, as well as any issues impacting marketed product

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



**3. 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 trouble shooting investigations

+ Participate in Continuous Improvement for processes and systems

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

+ Participate in Market Action / Product Recalls



**4. Local Product Disposition**



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

+ Review packaging artwork of fully finished products

+ Conduct transactions in Systems, Applications and Products (SAP)

+ Oversight of returned goods and Reprocessing

+ 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 Quality (ESQ) 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

+ Prepare and report on Key Performance Indicators and departmental activities in monthly management reports, S&OP meetings



**5.** **Inspections and Internal Audit**



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

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

+ Prepare Self inspection plan for the year and ensures the plan is met

+ Track the implementation of the identified actions within agreed timeframes



**6. Local Contractor Quality Oversight**



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

+ 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 MSQA audit findings to SCQ Greater China Cluster Lead 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



**7. 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



**8. Commitment Tracking**



+ Ensure Regulatory, Internal Audit and AQRT commitments are completed as required



**9. Change Control**



+ Ensure all changes are appropriately documented and approved as required



**10. Market Actions**



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

+ Responsible to establish appropriate service level agreements, performance requirements, monitoring metrics and issue management with local, regional or global teams that provide data and information systems services to the market

+ Lead or participate in various continuous improvement strategies and projects and own role appropriate projects

+ Manage and maintain the integrity of portfolio data and associated documentation

+ Manage coordination of key stakeholders locally, internationally and across cross-functional teams



**Educations**



+ Bachelor degree in Pharmacy, Chemistry, Biology, Microbiology, Biochemistry, Engineering or similar related disciplines



**EXPERIENCE**



+ A minimum of 5-6 years previous experience is required

+ Demonstrated ability to influence other work partner

+ Able to operate independently in ambiguous situations

+ Self-motivated individual who is comfortable with working independently

+ Strong communication and interpersonal skills

+ Good English skill in oral & written

+ Licensed Pharmacist is prefer



\#LI-PFE



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



Logistics & Supply Chain Mgmt

Categories

Posted: 2020-10-13 Expires: 2020-11-12

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Supply Chain Quality Supervisor, China

Pfizer
Beijing

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