Supply Chain Quality Manager
Pfizer
Casablanca, Morocco
il y a 3j
source : Tanqeeb

Title : Supply Chain Quality Manager -SCQ Manager - (Morocco)

Reported to : Supply Chain Quality Cluster Lead (ELI / Algeria / Morocco)

Organization overview

The key role of Pfizer SCQ is to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture within Pizer and any contractor related to GMP / GDP activities, so that compliance with Pfizer and Regulatory authority expectations and protection of Pfizer patients / customers from any product quality risk are ensured.

SCQ is the main point of contact for the investigation and resolution of all product quality issues discovered or originating in the PCO and for interacting with the relevant local stakeholders, PGS and local regulatory authorities on such issues.

Coordinates and monitors the product quality and compliance activities at the PCO to ensure that current regulatory expectations are met and facilitates internal and regulatory GMP inspections.

Acts as a qualified person responsible to local authorities and oversees Qualified person's activities for all Pfizer quality compliance issues, if needed.

Role description and Main responsibilities

Maintenance of the compliance to the local BOH regulations

Coordinate the product quality and compliance activities at the PCOs, to ensure current BOH expectations are met.

Act as the Qualified / responsible Person to local authorities or support Qualified Person activities for all Pfizer Product Quality Compliance issues in the market.

Governance & internal organization

Responsible for the timely implementation of all applicable GSOPs within the PCO.

Ensure SCQs and all relevant PCO colleagues are appropriately trained in the Product Quality SOPs.

Quality management review : Monitor KPIs, analyze collected metrics, evaluate and highlight any significant trends and identify actions.

Ensure metrics are tracked in the global system.

Conduct quality management and metrics review with relevant stakeholders.

Conduct / Oversee completion of internal assessments to ensure compliance with product quality systems and processes and to identify improvement opportunities.

Assess new or proposed quality system / local regulatory requirements and adjust / enhance local systems and processes when required.

Training

Support the implementation of all elements of SCQ Training systems in PCO, including implementation and refresher training on GDP / GMP to applicable PCO colleagues.

Ensure that all assigned Pfizer trainings ( P2L for example ) are completed in timely manner

Participate in regular meetings with relevant PCO stakeholders

Commitment Tracking

  • Manage commitments resulting from deviation management, change control, local regulatory authorities' inspections and internal audits.
  • Change Controls

    Manage planned, permanent and temporary changes of GMP / GDP related activities and systems in the PCO.

    Participate and or organize change's committee as appropriate and ensure the required approvals.

    Ensure change actions completion as per the agreed timelines. Inspection and Internal Audit

    Lead preparation and coordination of GMP / GCP / GDP / MAH related inspections of PCO Pfizer internal / MSQA audits

    Work with SCQ Sr Manager / TL and local functions to Prepare an appropriate action plan to address the inspection / audit observation.

    Responsible for implementing and tracking the commitments / identified actions within agreed timelines.

    Internal self-inspection process management :

    Setting the SI plan according to local needs and priorities

    Ensure the timely implementation of the self-inspection plan as per the assigned tasks as auditee and / or auditor.

    3. Product quality assurance & operations

    Notification to Management

    Notifies SCQ Sr Manager / TL and SCQ Regional Lead of significant product quality and compliance issues.

    Attend AQRT meetings, as PCO representative, to provide the local perspective on the issue at hand.

    Provide AQRT Executive Summary including local investigation results and proposed CAPAs for issues originating under the responsibility of the PCO.

    Ensure the local implementation of actions identified during AQRT meetings e.g. recalls, communication with Regulatory Agency, local CAPAs and provides feedback on progress Deviation and CAPA Management

    Perform investigation of product quality incidents that occur within the responsibility of Pfizer country office in cooperation with the relevant internal / external functions.

    Track the preventive and corrective actions until completion within the set due dates. Product Complaint Handling

    Oversee correct prioritization, categorization and timely reporting of products quality complaints originated in the local market and ensure compliance with applicable local regulations and GSOPs via the global complaints management system.

    Ensure that SCQ colleagues which are handling product quality complaints are trained to the SOP.

    Ensure correct prioritization, categorization and timely reporting of products quality complaints

    Local Product Disposition

  • Responsible to Review all documents and records relevant to the imported products and perform the necessary activities to provide a disposition decision to the products to the market sale in compliance with local regulatory requirements and Pfizer procedures..
  • Quality Oversight of local repackaging / relabeling operations

    Ensure relabeling / repackaging contractors have been assessed and approved

    Ensure local regulatory authorities approval of the repackaging / relabeling activities

    Ensure all needed Pfizer approvals are completed and escalate packaging requests for regional lead approval

    Ensure SCQs release of the repackaged / relabeled product according to the GSP / PQS and local requirements

    Notify Sr manager of deviations or concerns occurred / noted during repackaging / relabeling operations and any issues with the potential to impact marketed product

    Market Returns

    Responsible to define requirements under which returns can be taken back to saleable stock and supports local actions in cooperation with Logistics and Distribution Centers.

    Assess the returned goods and provide a disposition decision if applicable

    Quarantine Alert Notices

    Receive and manage Quarantine Alert Notices (QAN) issued by Pfizer manufacturing site, Contractor manufacturing site or distribution center.

    Ensure status of impacted batches at logistics center / LSP / contract vendor is changed to Blocked / Hold and then aligned with final disposition decided by QAN issuing site

    Provide the required responses to QAN issuing site on timely manner.

    Market Action

    Attends, as needed ( as backup for example ) , Area Quality Review Teams (AQRT) meetings, as principal PCO representative, to provide the local perspective on the issue at hand.

    Supports to provide the local perspective on the issue and draft AQRT Executive Summary for issues originating under the responsibility of the PCO.

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

    LSP / Contractor management & oversight

    Oversee quality operations at contractors or provide feedback to the appropriate functions

    coordinate, support and participate in MSQA audits

    Agree with contractors / LSPs on action plans to address observations noted during the audits or regular visits

    Document and track all CAPA plans.

    Notify SCQ Sr Manager of significant concerns or repeated deviations occurred with contractors and all issues potentially affecting marketed product. Quality agreements

    Develop, negotiate and maintain up to date quality agreements with all affiliate GMP / GDP contractors involved in manufacturing, repackaging, laboratory testing or activities at LSPs

    Market Business & global Support

    Actively participate in market forum as spokesperson on quality topics.

    Foster and grow departmental communications and networking to assist with the quality reviews and crises management.

    Participates in business initiatives giving advice and assessing the impact to product quality and compliance.

    Ensure effective communication and collaboration with Pfizer (PCO / affiliate) internal stakeholders to ensure alignment and optimal support, launches and continuous availability of quality compliant Pfizer products.

    Ensure effective communication to Pfizer sites and global / regional quality functions about local GMP and other regulatory requirements to ensure appropriate support and documentation for Pfizer products quality compliance release and maintenance in (PCO / affiliate)

    Work closely with other platform lines to achieve process development and improvements as ONE Pfizer.

    Actively promote the SCQ team

    Qualifications / Skills

    Years of experience 8-10 years in the Pharmaceutical or related regulated industry.

    Technical skills

    Has an appropriate education in science or quality topics; Bachelor's degree, pharmacist, Engineer.

    Has comprehensive knowledge of the quality principles, concepts of quality and comprehensive technical experience.

    Has strong technical experience with quality systems (change control, deviations, complaint management, documentation management, audits, inspections, etc.).

    Able to work and contribute effectively in cross-functional team, culture differences, diversity.

    Able to make sound and effective quality decisions independently in complex and ambiguous situations.

    Advanced judgement and analytical skills.

    Show strong negotiations and effective communication skills with internal and external business partners.

    Strong technical writing and presentation skills.

    Strong planning & organizing skills.

    Fluent in English language .

    Soft skills / management & leadership skills

    Self-motivated, confident with working independently, motivate others, Business acumen.

    Act decisively and take strategic decisions.

    Grow self.

    Hold People accountable.

    Influence others.

    Emotional intelligence skills and Knowledge.

    Success criteria

    Take appropriate risk to advance new concepts and methodologies that address technical and organizational improvement and encourages others to do the same.

    Provides guidance to team members and lead complex projects and situations.

    Evaluating and continuously improving affiliate quality systems to advance quality culture.

    Apply skills and discipline knowledge to contribute to the achievement of work within department.

    Contribute to the completion of routine work team related tasks.

    Build trust and credibility with internal and external business partners and regulatory authorities.

    Develops leadership skills.

    Efficiently represent quality compliance department.

    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

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