الوصف الوظيفي
Supply Operations Quality Senior AssociateWhy Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented.What You Will AchieveYou will be a member of Pfizer’s dedicated and highly effective quality operations team. You will evaluate and review Pfizer’s clinical and commercial batches of pharmaceuticals. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve ItThe key role of the SOQ Senior Associate is to establish and maintain an appropriate and sustainable Quality Management System and Quality Culture within the Pfizer Country Office (PCO) in order to ensure compliance with Pfizer and Regulatory Authority expectations.SOQ Senior Associate is the Quality Responsible Person related to distribution activities, focusing on the management of authorized activities and the accuracy and quality of records.SOQ Senior Associate is the main point of contact for the investigation and resolution of all product quality issues detected or originating in the PCO and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, Commercial, etc.) and Pfizer Global Supply (PGS) on such issues.SOQ Senior Associate monitors the product quality and compliance activities within the PCO, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP/GDP inspections.SOQ Senior Associate will be able to get support from Manager to achieve the purpose above.Key AccountabilitiesResolution of Product Quality and Compliance IssuesDeviation ManagementInvestigates, together with appropriate local functions, deviations from Product Quality and Compliance requirements that occur within the responsibility of the PCO and agrees 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.Customer Complaints HandlingEnsures that relevant customer complaints are dealt with, effectively.Manages the intake of product quality complaints from the local market and forwards them to the appropriate global teams.Tracks responses to product quality complaints. Develops and issues responses to complainants in a timely manner, if requested.Provides input form quality perspective to Commercial Departments for the resolution of customer complaints related to distribution activities.Notification to ManagementInforms PGS Quality Operations Management of significant deviations and complaints.Attends Area Quality Review Teams (AQRT) meetings, as relevant PCO representative and provides the local perspective on the issue at hand. Provides AQRT Executive Summary Report for issues originating under the responsibility of the PCO.Ensures the local implementation of actions identified during AQRT meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions.Quality Management SystemEnsures timely implementation of all applicable Product Quality SOPs (issued by SOQ) within the PCO. Ensures that initial and continuous training programs are implemented and maintained for all relevant PCO colleagues. Monitors key quality performance indicators, evaluates and highlights any significant trends and identifies actions. Ensures that self-inspections are performed at appropriate regular intervals following a pre-arranged program and necessary corrective measures are put in place. Assesses new quality system/local regulatory requirements and adjusts/enhances local systems and processes when required. Ensures that anyadditional requirements imposed on certain products by national law are adhered to. Keeps appropriate records of any delegated duties.Local Product DispositionResponsible for the local release of products under the distribution license of PCO, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country. Decides on the final disposition of returned, rejected, recalled or falsified products.Defines requirements under which returns can be taken back to saleable stock and supports local actions, in cooperation with logistics and distribution center.Coordinates and promptly performs any recall operations for medicinal products.Initiates the required actions if counterfeit products are identified.Inspections and Internal AuditsSupports the Responsible Person (RP) in the preparation and coordination of GMP/GDP Regulatory Agency inspections. Supports preparation and coordination of Regulatory Agency inspections internal Pfizer audits of Product Quality and Compliance (GMP/GDP) activities at the PCO. 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.Subcontracted Activities with GMP/GDP ImpactApproves any subcontracted activities which may have an impact on GMP/GDP: Develops, negotiates and maintains up to date Quality Agreements with GMP/GDP contractors, e.g. Logistics Service Providers (LSPs), relabeling/repackaging contractors. 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 and quality, generated at the contractor and agrees corrective actions. If necessary, initiates the “Notification to Management” process.Quality System Support: visits the contractor to assess quality systems, review quality performance and agree action plans to ensure continuous improvement.Issue and Review Metrics: periodically assesses the overall quality risk associated to the contractor. Acts on adverse trends in order to improve contractor quality and compliance performance.Facilitates the Pfizer Manufacturing Supplier Quality Assessment audit process at the contractor. Helps to define action plans for improvement and follow-up and communicate action closures.Quarantine Alert NoticesReceives and manages Quarantine Alert Notices received from Primary Logistic locations. Establishes if product lots remains at LSP and, if so, alerts the LSP to place the product on hold. Informs the Primary Logistic Location and PGS Site/ESOQ of quantity of product still within Pfizer control and follows the instructions regarding product disposition.Oversight of Local Relabeling and Repackaging OperationsEnsures relabeling/repackaging contractor has been internally assessed and approved. Obtains regulatory approval of the relabeling/repackaging activity. Coordinates all activities related to Pfizer products at the relabeling/repackaging contractor. Informs the releasing site of the relabeling/repackaging activity. Reviews documentation related to the relabeling/repackaging operation. When appropriate, releases the relabeling/repackaging product.Development and Maintenance of Consistent Quality CultureCollects data and metrics on the PCO’s quality performance and communicates this to the Management of SOQ, PCO and RP. This involves a regular Management Quality Review process. Provides ongoing education on Quality to relevant PCO functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture.Suppliers’ and Customer QualificationEnsures that suppliers and customers are qualified in accordance with GMP/GDP requirements. Provides local support, upon request, to the RP, for the customers qualification.Pharmacovigilance and the Compliance to Rules and Ethics CodesCompletes in due time the “Your Reporting Responsibilities: Monitoring the Safety, Performance, and Quality of Pfizer Products” (YRR) training program and the annual re-training. Reports information regarding drugs’ safety to the local Drug Safety Unit, in compliance with the YRR training materials. Has knowledge of and apply all the Compliance and Business Ethics rules. Reports any violation of the Compliance and Business Ethics rules.Personal development through active participation in Pfizer trainings, assignments, projects. Active involvement in Pfizer internal and external meetings from commercial perspective. Identifies personal areas of improvement. Maintains a good work-lifebalance.REQUIRED SKILL SETMust-HaveBachelor's Degree in science or quality topics3+ years experienceExperience in Quality administered systemsKnowledge of current Good Manufacturing Practices and the applicable GxP regulations and standardsProactive approach and strong critical thinking skillsExcellent communication and interpersonal skillsGood knowledge of Microsoft OfficeStrong negotiation and effective communication skillsSelf-motivated individual who is comfortable with working independentlyAble to lead and work effectively in cross-functional teamsNice-to-HaveMaster's degree and relevant pharmaceutical experienceWilling to lead by example and jump right in, desire to get to root cause, collaborative and active listenerEffectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure#LI-PFEPurposeBreakthroughs 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.School of LeadersWe, as Pfizer Turkey, make a difference with our visionary and pioneering approaches ranging from our concept of raising leaders through rotations, providing international career opportunities to creating a flexible, enjoyable work environment. There are no limits to what we can accomplish to touch lives here!FlexibilityWe 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 OpportunityWe 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.Quality Assurance and Control#LI-PFE
