Job Description

JOB FOCUS
Reporting to IO Quality Operations Manager – Return, QAN and Recall the role will support the Returns, the Quarantine Alert Notice (QAN) and Recall process as well as the associated quality decisions related to Pfizer’s portfolio that is distributed both physically and financially financially owned by the Legal Entities (listed in CD-76762) under the responsibility of Intercompany Operations (IO).
The role is responsible to ensure the continuity of supply of materials both financial as physical and the compliant management of materials under the responsibility of all Legal Entities managed by IO globally. Ensures compliance with Good Manufacturing/Distribution Practise (GMP/GDP) standards, legal requirements and according to Pfizer Policy.
The incumbent will interact with stakeholders within IO, such as Customer Service (CS); Logistic Delivery Operations (LDO); Inbound, Inventory, Controlled substances and Compliance (IICC); Intercompany Master Data (ICMD), Customs and Quality teams in Supply Chain & External Supply Quality (SCESQ) and manufacturing quality to ensure that Return, QAN and Recall activities of products is executed timely and in compliance with Pfizer’s Quality Standards and global regulations.
The incumbent will be responsible for in time deviations and commitment tracking management that are encountered during the Return, QAN and Recall processes and is responsible for the timely closure or extension of these records in the relevant Quality Management Systems (QMS).
The incumbent is responsible to ensure that all Return, QAN and Recall processes are clearly and up to date described in procedure and the site is inspection ready at any time.
The role is responsible for giving quality support to any improvement project within IO
JOB SUMMARY - MAIN AREA’S OF RESPONSIBILITY / ACCOUNTABILITIES
1
Quality Management - Return

• 
  Responsible to ensure all Return activities are covered by the authorizations and documented in an ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) manner
• Ensure the required documentation and physical checks (if applicable) are performed to allow Return disposition considering Global/Regional/National regulations (e.g., controlled substances).
• Support complex Return of controlled substances or Covid products and ensure that Global/Regional/National legislation is taken into account
• Conduct and document (complex) deviations/investigations associated with the Returns processes and present formal notifications of significant issues to senior management and Quality Review Teams
• Ensuring that relevant customer complaints are dealt with effectively
• Support and investigate/analyze the inventory changes/discrepancies in SAP following Return activities
• Ensure that the operations do not compromise the quality of Pfizer products

2
Quality Management - QAN
(20 %)

• Responsible to ensure all QAN activities are covered by the authorizations and documented in an ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) manner
• Ensure the required documentation, SAP status and physical checks (if applicable) are performed to allow QAN confirmation/disposition considering Global/Regional/National regulations (e.g., controlled substances) in a timely manner
• Ensure distribution of QAN documentation to receiving sites (if applicable) and LSPs in cooperation with the LSP oversight function (if applicable) in a timely manner
• Cooperate with stakeholders in order to ensure information about QANs is shared
• Conduct and document (complex) deviations/investigations associated with the QAN processes and present formal notifications of significant issues to senior management and Quality Review Teams
• Ensure that the operations do not compromise the quality of Pfizer products

3
Quality Management – Recall
(10 %)

• Support all Recall activities and responsible to ensure all are covered by the authorizations and documented in an ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) manner
• Ensure the required documentation, SAP status and physical checks (if applicable) are performed to allow Recall confirmation/execution considering Global/Regional/National regulations (e.g., controlled substances) in a prompt and timely manner
• Cooperate with stakeholders in order to ensure information about Recalls is shared
• Conduct and document (complex) deviations/investigations associated with the Recall processes and present formal notifications of significant issues to senior management and Quality Review Teams
• Ensure that the operations do not (further) compromise the quality of Pfizer products

4
Inventory management

• 
  Ensure the discrepancies during the inventory management related to Return, QAN and Recall activities are investigated and resolved in a timely manner

5
Project Support

• Support and participation in projects relevant to the team
• Continuous improvement
• Support the quality culture within IO

6
Quality system support

• 
  Responsible for keeping all Return, QAN and Recall processes clear and up to date described in procedures
• Ensure to keep appropriate records of any delegated task/duties
• Ensure maintenance of quality systems and associated electronic system changes for Return, QAN and Recall activities
• Responsible for the timely closure or extension of Return, QAN and Recall records (deviation; commitment tracking; CAPA) in the relevant Quality management Systems (QMS) in compliance with internal standards and EU GxP.
• Ensure accurate and timely maintenance of SOP/WI’S related to quality inventory management
• Support change management activities relating to legal entities compliance activities
• Support inspection readiness for BOH inspections and external vendor audits
• Collaborate with internal and external stakeholders to resolve quality issues and ensure compliance to EU GxP standards
• Ensure the metrics are reported for Return, QAN and Recall activities
• Support the site self-audits upon request following a prearranged program and necessary corrective measures are put in place

KEY PERFORMANCE INDICATORS (KPI)
List the more general result area’s in which results (output) of the job can be measured.

• No delay in supply following late disposition of products
• No delay in supply following late investigation of T° excursions or transport incidents
• Comply with defined lead-times and escalate in time
• Comply with and adhere to all procedures
• Works according to relevant SOPs and WIs
• Meet set departmental and individual objectives
• No critical or major finding as a result of BoH inspections or RQA audits linked to job profile activities
• Timely delivery of metrics
• Completes all required training in due time

QUALIFICATIONS
List the technical skills and knowledge. These will be the minimum entry requirements and necessarily know how for the job.

• Level of Education

Scientific background, or equivalent through operational experience in GMP/GDP environment.

• Experience

2-5 years quality or relevant work environment.
Expertise with complex supply chain is an advantage.
Knowledge of GxP beneficial.

• Languages

Fluent English written/spoken, with additional languages as an advantage.

• Computer skills

Knowledge of usual Microsoft applications (Outlook, Word, Excel, PowerPoint).
SAP/ERP experience beneficial.
Previous use of Trackwise®/Veeva Vault beneficial.
COMPETENCIES – PERSONAL CAPABILITIES
Identify specific personal capabilities necessary to lead to outstanding performance in the job.

• Stress resilient, change agile and analytical mindset.
• Takes initiative and ownership to deliver on time without compromising on quality.
• Dynamic, flexible, enthusiastic and eager to learn.
• Insight and understanding of stakeholders needs and requirements.
• Ability to work under minimal supervision and in a team.
• Able to demonstrate good planning and organisation skills.
• Ability to apply technical knowledge and understanding to making appropriate and timely risk based decisions.
• High level of self- integrity and ethical conduct.
• Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA) is a strong asset.

#LI-PFE
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control