Responsible Person on Quality
- Компания: Pfizer
- Город , Almaty,
- Зарплата:
- Размещено: 2025-06-25 22:47:25
Описание
Responsible Person (RP)’s responsibilities are explicitly listed in the Kazakhstan regulation requirements and EAEU Good Distribution Practice (GDP) legislation.Per the P legislation, the RPs fulfil their responsibilities personally and should be continuously contactable (24/7). The responsible person may delegate duties but not responsibilities.The RPs are listed on the wholesale distribution license must meet the qualifications and conditions stated in the local legislation , with relevant experience in the GDP environment.RP must carry out their duties in such a way as to ensure that the PCO with WDL can demonstrate GDP compliance at any time and that public service obligations are met. RP is responsible for the entire GDP Inspection readiness program at the PCO as well as for hosting the GDP BoH inspections and for coordinating the creation of the CAPA Plan and for ensuring all commitments toward the BoH are timely met.The RP has personal liability for all GDP dispositions decisions taken.RP is overall responsible for the GDP processes, mandatory to be established, maintained and managed in GDP compliance in the PCO holding the wholesale distribution license:Owned by Quality: Management of Procedural Documents, Management of GxP Records, Training, Commitments, Management of BoH inspections/Audits, Self-Inspections, Vendor Quality Management, Quarantine Shipments, Quality Investigations, Notification to management, Market Actions, Management Review, Risk management, Health Authority Notifications, Relabeling/Repackaging, Regulatory Monitoring, Quality Agreements, Management of GxP Equipment and Instrument, Global Batch Release, Incidents during Transportation and Storage of Pfizer Products, Returned Goods, Change Controls, Quarantine Alerts Notices, Product Quality Complaints including Serialization Alerts, Qualification of suppliers (invoicing entities), Qualification of customers, Management of BoH exemptions, Reporting of Drug Shortages (split between SCMOQ and Regulatory across markets).Oversight of GDP processes owned by Global Supply Chain and/or Customer Service: Inventory Management, Product Destruction, Drug shortage management, Market to Market Transfers, Management of Customer orders, Distribution complaints.Shared responsibilities with Regulatory for the investigation of labeling errors originating in Regulatory, with impact on product quality.Oversight of Distribution of free samples under GDP/scope of WDL (process owned by Commercial)RP is overall responsible to oversee the GDP warehousing activities outsourced to the Logistic Service Provider (LSP).RP acts as a single point of contact with the BoH on all product quality and GDP related matters – quality issues, recalls, negotiation with the BoH on BoH concurrence for the Pfizer recommendations (e.g. to recall, stop distribution, continue distribution).RP is responsible to ensure that initial and continuous training programs are implemented and maintained for all colleagues performing GDP activities (Quality, Global Supply Chain, Customer Service, etc).Lead and support quality projects and continuous improvement initiatives
Plan and track actions to ensure timely completion of commitments from new product introductions, Pfizer Quality Standard changes, regulatory audit commitments, and Supplier Audits
Take appropriate risks to advance innovative processes and methodologies based on business knowledge
Apply skills and discipline knowledge to contribute to departmental work, make decisions to resolve moderately complex problems, and operate independently in ambiguous situations
Here Is What You Need (Minimum Requirements)
BA/BS in PHARMACY with at least 2 years of experience or MBA/MS PHARMACY with at least 2 years of experience
Advanced computer skills in MS Office and enterprise systems like SAP, QTS, and Documentum platforms
Exceptional verbal and written communication skills, including the ability to deliver compelling presentations
Proven track record in managing multiple projects and handling complex contractors
Strong negotiation abilities
Experience in Product Quality Assurance within a GMP (Good Manufacturing Practices) environment
Demonstrated ability to work independently and make decisions in ambiguous situations
Fluent in English
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Quality Assurance and Control