JOB FOCUS

The key role of the SCMOQ Officer is to support Panama SCMOQ Manager on establishing and maintaining an appropriate and sustainable Product Quality System and Quality Culture at Logistic Service Provider (LSP) and Panama Pfizer Country Office (PCO) in order to ensure compliance with Pfizer and Regulatory Authority expectations.

Provides support to the Panama Quality Operations Department with the implementation, performance and monitoring of Product Quality and Compliance (GMP/GDP) Quality Systems and compliance related initiatives within the Logistic Service Provider.

In addition, the SCMOQ Officer will be the main point of contact for the investigation and resolution of product quality issues discovered or originating at the LSP, product complaints (CITI) management and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, other business units) and Pfizer Global Supply (PGS) on such issues.

Also, the SCMOQ Officer will monitor the product quality and compliance activities at the LSP doing at minimum 1 visit per week to their facility located in Colon city, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP inspections. Quality contact for product quality compliance issue and resolution. The position will act as the Panama SCMOQ Manager Backup for the quality activities in Panama.

JOB SUMMARY - MAIN AREA’S OF RESPONSIBILITY / ACCOUNTABILITIES

The responsibilities of the SCMOQ Officer are guided by Pfizer Quality Standards (PQS) - which are translated into local SOPs / GSOP- and by local regulations. Scope of the responsibilities: All Pfizer Products. Ensures full compliance of the Panama LSP with government and Pfizer policies, procedures, guidelines and regulations.

SCMOQ Officer responsibilities may include some or all of the following, depending on the scope of PGS activities in the country

1. Resolution of Product Quality Compliance Issues

• Deviation Management
  • Management Investigates, together with appropriate local functions, deviations from Product Quality and Compliance requirements that occur within the responsibility of the contractors, Intercompany Operations (IO) representative, PCO Panama and tracks preventive/corrective actions. Local investigations may relate to product damage, artwork and labeling errors, counterfeits, temperature excursions during transport or issues with contract manufacturers or logistics service providers etc.
  • Provide trends and updates to PCO leadership.
• Product Complaint handling
  • Support the complaints’ intake process from the LSP.
  • Tracks complaint responses and resolutions on CITI (apply to LSP, including the follow up of the LSP deviations).
  • Develops and issues responses to complainants in a timely manner when it is applicable.
• Notification to Management
  • Support the Notification to Management process and/or a notification to Regulatory Authorities, in/for the required market(s).
  • Attends Area Quality Review Team (AQRT) meetings, when it is applicable, to provide the local perspective on the issue at hand. Provides AQRT Executive Summary for issues originating under the responsibility of the Contractors or SCMOQ Panama Quality System.
  • Ensures the local implementation of actions identified during AQRT meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions (CAPA).

2. Product Quality System

• Ensures timely implementation of all applicable Product Quality SOPs / GSOPs (issued by QO) within PGS. Act as the Change Control processs Owner.
• Ensures that all relevant PGS colleagues are appropriately trained in the Product Quality SOPs / GSOPs.
• Support SCMOQ Panama Management on monitoring key quality performance indicators, evaluates and highlights any significant trends and identifies actions.
• Conducts internal assessments to evaluate compliance with product quality systems & processes, and to identify improvement opportunities.
• Notify SCMOQ Panama Management on any relevant issue or observation identify during internal assessment execution.
• Assess new quality system/local regulatory requirements and adjusts/enhances local systems and processes when required.

3. Local Product Disposition

• Where required, performs local release of imported products, reconditioned products and packaging materials in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.
• When required, defines requirements under which returns can be taken back to saleable stock and supports local actions, in cooperation with logistics and distribution center.

Administrate material status within the distribution network. This includes:

• Coordinate or perform the inspection of products entering the Logistics Center, in accordance with the requirements of Supply.
• Ensure that products comply with the current release technical documentation.
• Ensure compliance and disposition of products according to existing arts, regulatory and quality requirements.
• Inspections of product and materials to approved specifications and provide final disposition status.
• Review Technical Specification sheets, for approval of reconditioning instruction to LSP.
• Support the Panama Manager to lead or assist in root cause investigation in the event of a non-conformance, related to any of the regulatory areas described above and during the incoming inspection shipments from the manufacturing sites. Present formal notifications of significant issues to senior management and Quality Review Teams.

4. Inspections and Internal Audit:

• Support SCMOQ Panama Management on preparation and coordination of Regulatory Agency and internal Pfizer inspections of GMP/GDP activities at PGS. Works with local functions to define an appropriate action plan to address the inspection/audit observation.
• Tracks the implementation of the identified actions within agreed timeframes.
• Manage Annual Self- Inspection Plan within the scope of SCMOQ activities for Global and Local Procedures in Panama PCO.

5. Local Contractor Quality Oversight

• Supports SCMOQ Panama Management to maintain up to date Quality Agreements with GMP/GDP contractors involved in manufacture, repackaging and activities at Logistics Service Providers.
• Oversees quality operations at contractors, which includes but is not limited to:
  • Contractor Assessment and Approval: ensures all GMP/GDP contractors have been formally assessed and approved.
  • Deviation Management: evaluates the impact of all significant deviations affecting Safety, identity, strength, purity & quality (SISPQ), generated at the contractor and agrees corrective actions. When required, initiates the “Notification to Management” process.
  • Quality System Support: assess contractor quality systems, review quality performance, agree action plans to ensure continuous improvement and support/notify SCMOQ Panama Management of any relevant issue identify. When required, support SCMOQ Panama Management on quality reviews during Business Review Meeting (BRM), where existing.
  • Issue and review Metrics: Periodically assess the overall quality risk associated to the contractor and its properly archiving into GMP system. Act on adverse trends in order to improve contractor quality and compliance performance.
• Facilitates the Pfizer Manufacturing Supplier Quality Assessment (RQA) audit process at the contractor. Helps to define appropriate action plans for improvement and follow-up and communicate action closures.

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

• When required, receives and manages Quarantine Alert Notices (QAN) received from Primary Logistic locations. Be the principal point of contact for any requirement of blocked inventory due to a GMP deviation.
• Establishes with LSP if product lots remain at the site and, if so, alerts the LSP to place the product on hold.
• Informs the Primary Logistic Location and PGS Site/ESQ of quantity of product still within Pfizer control and follows further instructions regarding product disposition.

7. Oversight of local Repackaging and Relabeling Operations

• Ensures relabeler / repackager has been assessed and approved.
• Obtains regulatory approval of the repackaging/relabeling activity, if required under the local regulations.
• Informs the releasing site of the repackaging/relabeling activity.
• Reviews documentation related to the repackaging/relabeling operation such as the GSOP21 (ex-PQ11) form and supervise the signature process of that form.
• Releases the repackaged/relabeled product.

8. Development and Maintenance of Consistent Quality Culture

• Collects data and metrics on PCO and LSP quality performance and communicates this to PCO Management. This may involve a regular Management Quality Review process.
• Provides ongoing education on Quality to relevant PCO and LSP functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture.

KEY PERFORMANCE INDICATORS (KPI)

Opened and overdue deviations per months

• Repeated observations or critical findings during internal audits or inspections
• Works accordingto relevant SOP / WI.

QUALIFICATIONS

• Level of Education

An appropriate education in science or quality topics

• Experience

Pharma Background Desired.

Has experience in Quality Systems in a Biopharmaceutical environment.

Has Pharma Logistic Service Provider (LSP) and vendors quality oversight experience.

• Languages

English language communication verbal and written.

• Computer skills

Computer literate.

COMPETENCIES – PERSONAL CAPABILITIES

• Managerial
• Makes sound and effective quality decisions under pressure.
• Diplomatic in communication with internal and external customers.
• Show strong negotiation and effective communication skills. Is influential.
• Self-motivated individual who is comfortable with working independently.
• Able to lead and work effectively in cross-functional team & collaborate.

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.