Opinioni Pfizer Catania

Role Description

Assure the supply in the market of a part of the Pfizer product portfolio ensuring the continuous availability of products to the patients .

Responsibilities

Demand Planning & Forecasting (DPF)

Monthly Brand forecast reviews (BFR) and timely system updates interacting properly with AMP Hub colleagues Ensure adequate optimal stock level at local LSP, ensuring products are available to Pfizer customers and patients Timely communication of Out of Stock (start-end) and shortages in the market

Sales & Operating Planning (S&OP)

Lead monthly Sales & Operating Plan process and meeting with cross-functional participation from Sales, Marketing, Regulatory and Finance sharing supply chain performances and commercial info/needs Ensure a structured S&OP action items follow-up and escalate to AMP Hub as required

Lifecycle Product management (PCM)

Coordinate Supply Chain activities in case of sourcing change, new product launches, loss of exclusivity, artwork changes Liaise with regulatory and commercial ensuring timely product supply aligned with registrations and regulatory changes SAP Item Master data maintenance Inbound product flow: STO/PO/Return/Info record/Transfer Price/Flex-R/Customer-Vendor PEH Item Discontinuation process coordination

Other Demand

Focal point for Inventory Value and slow moving/obsolescence analysis (DPF) “Demand Planning governance” lead for the market & FERCA mgmt. (DPF) Local Demand Tool mgmt. (DPF) SAP GTS mgmt. for psychotropics import

Qualifications

Degree in Engineering Management / Logistics / Supply branches Master Post-graduate courses in Logistics/Supply as added-value competence (preferred) Ability to write and speak English and have multi-cultural awareness Experience of using inventory management systems and processes to manage accurately data Highly PC literate, with detailed knowledge of relevant data manipulation systems and software packages, including SAP and Office Suite. Extensive ability to handle Access software and spreadsheets and perform advanced data analysis In-depth knowledge of supply chain strategies, tactics and activities, inventory control ideally gained in a pharmaceutical environment Similar supplier management experience gained in a manufacturing/production or pharmaceutical environment Team working and co-operation: high interpersonal skills necessary to work in a team environment and provide information to relevant parties. Initiative / self-starting: ability to work on own initiative and plan own workload on a day-to-day basis. High project management skills

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Pfizer is recruiting QA Aseptic Micro Compliance Specialist for the Manufacturing site in Catania

Mission:

The importance of the role is due to the responsibility towards the Site, the Company, and the Regulatory Agencies for aseptic behavior and microbiological activities of pharmaceutical goods for human use.

QA Aseptic: Quality Operations carried out in the Production Department for manufacturing products. Environmental Monitoring Program and Data Trending of the Manufacturing Areas and Supporting Utilities and in process controls.

Main Responsibilities:

All compliance aspects related to the EM program and process simulations; Aseptic behavior program oversight including program improvements and field assessment; Act as a “quality” point of contact for all activities related to micro aspects (validation, operations, engineer, maintenance); Proactively participate in network initiatives related to aseptic & micro aspects organizing internal training sessions; Updating and Using Relevant Knowledge - Keeping up-to-date technically and applying new knowledge to your job; Through trend evaluation assure robustness of root cause analysis and efficacy of CAPAs implemented related to micro aspects; Timely identify adverse trends related to micro aspects; Assure proper notification to management is followed for critical event or adverse trends related to micro aspects.

Qualifications:

A Scientific degree in: Biology, Microbiology, Chemistry, Chemistry and Pharmaceutical Technologies, Pharmacy; At least 5 years of experience in an aseptic facility covering aseptic and micro responsibilities. Preference with experience in the QO organization; Proven Knowledge of aseptic behaviors, design of areas and equipment; Strong Knowledge and expertise of regulations related to the manufacturing of sterile products (EU GMP Annex 1, FDA guidelines and so on); Proven knowledge in establishing trends and, on how to evaluate scope and impact of events related to micro aspects; Have a well-balanced and strong GMP knowledge and good understanding of key processes /systems / equipment /utilities; Able to interact with Corporate SMEs and External Stakeholders; Ability to interact with regulatory agency inspections; Ability to interact with production, QC and QA Investigation departments; Good knowledge of English language (written and spoken); Knowledge of process/systems/equipment/utilities.

Preferred Qualifications:

Experience in the handling of investigations; Proven Knowledge in Root cause analysis techniques.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Pfizer is recruiting an expert and enthusiastic Validation Supervisor for the manufacturing site in Catania.

Mission

The Validation Supervisor will be responsible for validating/qualifying the systems, equipment, utilities used to manufacture and/or clean drug products within manufacturing facility located in Catania, Italy. S/he will help to demonstrate systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products. knowledge of GMP and management of quality through quality systems. Member of Compliance forum and Validation Network.

The incumbent will be responsible for leading a team of specialists.

Main Responsibilities

Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines. Coordinates and communicates all testing with affected functional groups and evaluates test results. Executes validation activities to include Change Control initiation, protocol preparation, scheduling, protocol execution, data review and final report generation. Participates and presents data in Regulatory Agency, Customer, Corporate and Internal audits when necessary. Participates in development/ improvements to the validation program as needed to remain current with cGMPs and industry standards. Participates on teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment. Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA). Supports cleaning program through swabbing and visual inspection. Supports aseptic operations during media fill simulations, autoclave and lyophilizer re-qualifications and area requalifications. Provides support for additional focus area if needed: Automation, Facility Support. Assists in ensuring future equipment meet the technical requirements of the operation. Contributes to the selection and integration of new equipment and services, ensuring validation, quality requirements and the process capability of the equipment is in line with pre defined needs. Supports and develops equipment/services robustness and manage the risks and impact of failure. Manages minor projects which include all operational and financial aspects. Drive quality, safety and continuous improvement related activities. Delivers training and support to ensure efficient use and deployment of equipment. Leads a team of specialists assuring a proper coaching, coordination and problem solving.

Qualifications

Bachelor or Masters degree in Engineering, manufacturing technology or closely related field, or combination of education and work experience. 3 years of pharmaceutical industry experience required for consideration. People management experience is considered a plus

knowledge of GMP and management of quality through quality systems.

Some knowledge and experience with equipment, facility, utility or computer system validation, as related to sterile products preferred.

Understanding of process parameters, process scale-up, and knowledge management with experience of trouble shooting manufacturing and equipment/facility processes. Understanding of facility design and associated building management systems. Suitable understanding of engineering operations including, instruments, controls and mechanical aspects of pharmaceutical manufacturing equipment and associated services. Planning and organizational skills to project manage the operational and financial aspects of capital projects. Good interpersonal, organizational and communication skills (both oral and written) and demonstrated skills in team matrix working. Proven ability to deliver technical reports and presentations. English knowledge

Other Info

The job requires to operate pieces of manufacturing equipment and may require business trips for FATs as well as business meetings (may require travel). Standing, walking, bending, climbing, reaching and lifting upward of 25 kilos may be required. Personal Protective Equipment such as gloves, a full Tyvek suit and breathable air or filtering face piece may be required. The incumbent must be able to work multiple shifts as needed to meet deadlines

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.