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Organization overview
The key role of Pfizer Supply Chain Quality (SCQ) is to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture within Pfizer 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. 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 GxP 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 PCO, to ensure current BOH expectations are met.
Act as the Qualified/ responsible Person to local authorities for all Pfizer Product Quality Compliance issues in the market.
Ensure the timely renewal of Pfizer Gulf GSP license at LSP Agility warehouse.
Apply and follow up for the necessary controlled permits issued by Ministry of health & protection-UAE.
Perform the MOH export inspection for all Pfizer outbound shipments and coordinate the same with Pfizer and Agility customer service teams.
Establish and maintain excellent networking and relations with Health authorities, also act as contact and key liaison between Pfizer and the Ministry of Health concerning site inspections.
Governance & internal organization
Responsible for the timely implementation of all applicable GSOPs within the PCO.
Ensure Supply Chain Quality (SCQs) and all relevant Pfizer Country Office (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.
LSP (Logistic Service Provider) oversight
Oversight of all GDP activities, processes, and procedures at LSP that are related to Pfizer products to ensure compliance
Plan and perform the quality visits and follow up on findings/ recommendations.
coordinate, support and participate in RQA audits
Agree with contractors/LSPs on action plans to address observations noted during the audits.
Document and track all CAPA plans.
Notify SCQ Manager/TL of significant concerns or repeated deviations occurred with LSP/contractors and all issues potentially affecting marketed product.
Maintain the quality metrics of LSP and regularly update it on the relevant portals.
Identification and reporting of EHS related risks to higher management, ensuring corrective and preventive actions are taken as per guidelines.
Ensure that LSP procedure are in line with Pfizer quality requirements.
Ensure all goods are stored and transported in accordance with the defined transport temperature specification and Pfizer Quality Standards (PQS). This includes transportation to and from the LSP facilities to customers.
Provide support to external logistic centers when applicable as well as to cross dock locations with regards to quality related aspects.
Ensure that the transportation team and the warehousing team receive all information relevant to products’ storage and products’ transportation in accordance with the label claim / defined transport temperature guidance and Pfizer Quality Standards (PQS).
Ensure GDP/GMP validations performed in the Warehouse facilities (Temperature mapping of warehouse including cold rooms, fridges, warehouse operations and delivery trucks).
Responsible for Value added activities as per Pfizer processes which involves, sample retention, approval, ledger maintenance as per regulatory requirements.
Product quality assurance & operations
Manage all activities related to QMS as detailed in the Job Description in accordance with Pfizer Quality Standards (PQSs) and SCQ Global Standard Operating Procedures (GSOPs) , including Commitment tracking, Training, Change Control, Audits & Inspections, Notification to Management, Deviation Investigations and CAPA Management, Product Quality Complaints, Local Product Disposition, Returns, Quarantine Alert Notices, Market Actions & Recalls, Quality Oversight of local repackaging/relabeling operations, Quality Agreements, etc..
Qualifications/Skills
Has a Pharmacy Bachelor’s degree or higher
Holds a valid UAE MOHAP Pharmacist License
Years of experience 5-10 years in Quality GMP/GDP role or equivalent role in pharmaceutical industry.
Technical skills
Networking and communication skills, especially with MOHAP inspectors and key internal and external stakeholders.
Has comprehensive knowledge of the quality principles, concepts of quality and comprehensive technical experience.
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 Arabic and English languages.
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.
Change agile.
High self-awareness.
Influence others.
Emotional intelligence skills and Knowledge.
Work Location Assignment: On Premise
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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