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 Pfizers QMS Ensure any changes that may require a variation to marketing authorization, manufacturing license or GMP clearance are notified to management as per Pfizers 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