Tapi - Qc Operation Laboratory Manager jobs at Teva in Italy

• Support and identify new business opportunities and share them with sales functions.
• Maintain relationships with local suppliers for the provision of "dossiers."
• Fill any portfolio gaps through BD-L activities.
• Manage the GAP process.
• Main interface with Global/EU BD, Procurement, and Pipeline functions.
• Evaluate new business opportunities for GX products, including potential upgrades or innovative/differentiating aspects.
• Evaluate possible out-licensing.
• Evaluate European Pipeline projects, including NTEs and Innovative FDCs, and their positioning in the Italian market.
• Collaborate with the company functions involved in the LRP process for the correct integration of the future pipeline.

Background:

• Bachelor's or Master's degree in Finance, Economics and Business, CTF, or equivalent education
• Previous experience in Project Management
• Previous experience in in/out licensing and/or business development
• Previous experience in pharmaceutical companies (at least 3 years), preferably within multinational companies
• Excellent knowledge of English

Skills:

• Strategic vision
• Internal and external customer focus
• Excellent execution
• Collaboration and influence
• Change management
• Business acumen
• Professional expertise
• Strong negotiation skills

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Medisspecializes in out-licensing high-quality generic pharmaceuticals to third-party pharmaceutical companies. Established in 1985, we offer a broad portfolio of 170+ generic pharmaceutical products, mainly in the form of tablets, capsules and injections.

Our portfolio includes a growing range of specialist oncology products and product formulations, predominantly solid oral dosages.

As ayou will play a critical role in developing market strategies in your responsible market (Italy), leading and executing in market B2B business development and key account management within the pharmaceutical space.

• Prioritise and analyse the responsible markets and develop a strong market strategy in collaboration with EU Cluster head
• Identify profitable portfolio and sales gaps for the markets / and or with strategic partners
• Responsible for keeping track of market trends that can influence the Medis business and thereby identifying new opportunities
• Maintain a good overview of current activities, follow up on the defined sales strategies and provide regular updates to the Cluster team.
• Organizes the markets within the Cluster. He/ She manages the daily work of the market/s and the planning to deliver on KPIs
• Work closely with the Cluster team on their day-to-day operations in order to add value to organization’s profitability, growth and international reputation and ensure that objectives are met
• Responsible for driving commercial results in the market/s in line with budget and the sales in the region
• Responsible for his/her respective market/s in the negotiations of offers, new agreements and amendments with new and existing customers
• Provide market intel on market price strategies and price amendments in line with local landscape
• Responsible for reviewing and advising on action plans on low margin products / agreements
• Advise on dispute solving and settlements, including decisions on provisions thereof
• Requirement to review and update CV and JD regularly to accurately reflect role
• Responsible for any additional specific tasks/projects as assigned by the EU Cluster Head

• Bachelor’s Degree in Pharmacy, Business or related field of study
• 8+ Years of commercial experience
• Experience with contract negotiations and knowledge of regulatory /compliance requirements preferred
• Experience or knowledge in regulatory and legal/IP will be highly regarded
• Fluency in written and spoken English language
• Strong leadership with ability to lead for success
• Commercially focused with high numeracy and good analytical skills
• Strong business partnering, interpersonal and communication skills
• Ability to develop and successfully execute commercial strategy from lead generation to sales.
• Ability to work well in high pressure situations in order to meet deadlines
• Strong project management skills with ability to deliver solutions on target and on budget, while generating superior results
• The capacity to grasp the many challenges of the generic pharmaceutical industry, be comfortable in a fast paced environment with multiple projects, working across the business as required.

Medis European Markets Cluster Head

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With
the industry's broadest portfolio including over 350 API products, TAPI is the go-to global

We are looking for a Sr Manager, Microbiology-Quality Compliance Expert - TAPI.
The main purpose of your job will be to ensure that the Microbiology laboratories, systems , procedures related to Quality Compliance System at TAPI sites is in place, securing compliance of activities, OOS investigations, Micro CCS, quality risk management, escalation of risks, and continuous improvement. Your role will include providing governance through strong collaboration with manufacturing site operations to foster excellence in inspection management and inspection readiness at TAPI sites. You will support manufacturing site remediation activities directly.This role will ensure that each site receives the right level of support to sustain and continuously improve GMP compliance related to Microbiology and other quality compliance support, to strategize the development and overall implementation of remedial plans, to solve quality-related compliance issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance with TAPI standards. Moreover, you will foster and develop onsite Quality culture across all sites.

• Support the Implementation of the Site Inspection Readiness Program focusing on Microbiology labs and related areas
• Input, Review and Approval of Complex Investigations ( OOS, Deviations, Incidents, etc.)
• End to End Support for Health Authority Inspections focused on Microbiological aspects
• Support the Implementation of Quality Risk Management
• Review and Monitor Quality Improvement Plans
• Train Site Colleagues on the Microbiology fundamentals, investigations, and Corporate Standard System
• Support Global Quality Compliance Initiatives eg; Cross contamination strategies
• Data Reliability assessments, gap evaluations, GxP data mapping in the micro labs
• Review global TAPI policies and standards and provide inputs
• Expected to spend reviewing QMS areas outside microbiology subject that related to QIPs, Data trending, signal detection, managing quality forums, leading CoPs related to Microbiology and relevant Quality management systems ( CAPA, Investigations, QRM etc)

• Establish and monitor governance on data integrity requirements.
• Cooperate with other functions on Quality projects and their role out.
• Act as a quality SME and support global compliance initiatives upon request
• Participate in audits upon request.
• Fosters knowledge sharing among sites within the TAPI

• Degree in Industrial Microbiology and demonstrated knowledge in cGXP regulations.
• 10+ years' experience in GMP environment, continuous professional development 5+ years' experience in Microbiology laboratory, managerial tasks, organization Exposure to International working environment
• Mix of experience in Micro, Quality systems would be preferred.
• Very good understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, etc.
• Sound knowledge of regulatory standards and guidance in Pharmaceutical Industry and expectation of global regulatory bodies, including US FDA, PMDA and ANVISA requirements
• Performance management and reporting
• Project management, monitoring, execution and reporting
• Problem solving and good team work skills
• Proactive orientation, communication skills
• Proven influencing capabilities
• Fluent in English

TAPI will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment. More information on this verification and vetting will be provided if you reach this stage of the application process.

If you are a current TAPI employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to TAPI employees. Use the following link to search and apply:

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

1.Budgeting and Forecasting:

• Lead the budgeting and forecasting processes for the company, ensuring accuracy and alignment with strategic goals
• Monitor financial performance, tracking actuals against the approved plan, and conduct detailed variance analysis to highlight key trends and deviations.
• Lead annual and long-term planning cycle for the business; establish timeline, processes, assumptions and investment framework in partnership with stakeholders
• Manage the end-to-end process ensuring accurate and comprehensive LRP preparation.

2. Business Partnering for Support functions and MIS Reporting:

• Prepare monthly, quarterly, and annual financial forecasts, highlighting variances and providing insights to support decision-making.
• Build a monthly reporting package that quickly highlights results and insights for all key parameters and KPI
• Analyze business performance across various verticals, identifying trends and providing actionable insights to senior leadership
• Monitor performance against budgets and forecasts, identifying risks and opportunities for improvement.

3. Strategic initiatives:

• Assist in strategic financial projects
• Assist in pre and post deal signing requirements
• Assist in automation projects like CEO dashboards

• Chartered Accountant (CA) or MBA from a Tier 1 institute.
• A minimum of 5+ years of relevant experience.
• Experience in Pharma and in business unit finance roles or FP&A roles is highly preferred.
• Proven track record of involvement in technology upgrades, including the rollout of new tools in the FP&A space, is a strong advantage

Director Finance Operations

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

In the Environmental Health and Safety Department, we are looking for a brilliant profile reporting to the Site General Manager with the following responsibilities and activities:

Lead EHS Regulatory Compliance
Provide guidance to site managers and employees, conduct internal and support external audits, to ensure compliance with all applicable requirements. Design corrective and preventative action plans.

Assess and Mitigate Risks
Identify EHS risks and define proactive mitigations. Ensure that site investment and changes in processes, equipment and systems are carried out in accordance with the concepts of EHS by design and relevant EHS requirements and cGMP.

Promote a Sustainable EHS Culture
Create and maintain an EHS culture throughout the site that inspires a proactive attitude and a firm belief that ‘target zero’ is achievable. Create a space where people can speak openly and are encouraged to present new ideas about EHS stewardship.

RSPP role on site

SAFETY RESPONSIBILITY:

Preposto per la sicurezza “according to the Italian Law D.Lgs 81/2008”:
Person, that in accordance to professional skills and function, supervises the work and ensures the implementation of the directives received, monitoring the successful execution by workers and exercising a functional power.

Essential requirements:

• Ensure that the organization’s Quality Management System is fully applied within the area of responsibility maintaining total compliance to current GMP, GDP, Data Integrity requirements.
• Ensure adherence to environment, health and safety company requirements as well as legal obligations.
• Behave according to company Ethical Code and company values.

Education:

• Minimum: Bachelor's Degree: engineering or related science-based. Master's Degree in Safety / Industrial hygiene / Environment is an advantage.
• Professional certifications a must when required legally. Other professional certifications, i.e. CSP, CIH, are considered a plus.
• Experience with management systems such as ISO 9001; ISO 14001; OHSAS 18001

English and Italian: fluent

Minimum: 4 years work experiences in EHS in a chemical or pharmaceutical industry.

We try to take care of our employees, offering them small and large benefits. By way of example:

• Ticket Restaurants for each working day
• Working flexibility for Caregivers and parents
• Recognition Program
• Welfare Platform
• Highly inclusive and multicultural working environment
• Continuous learning and development programs (with full access to Linkedin Learning!)

Type of contract: long term contract

Villanterio (PV), from Monday to Friday.

The Automation Engineer is responsible for leading teams to deliver project(s) that span across one or more business units, Manage resources, schedules, financials, ensuring that the assigned site projects are duly finalized, in compliance with the project schedule and within the defined budget. You will be required to support and engineer solutions related to Control and Automation system scope of existing systems as well as new or modified systems.
Responsible for the execution of the Pharma Automation Design engineering portion and maintenance of a multi-discipline Concept Design, Basic Design & EPCm Scope of work on one or more projects, maintenance/ work scopes. Overall responsibility involves Leading a Automation engineers(contractors) to undertake Automation Engineering Design activities while meeting HSE, Quality, schedule, and budget performance goals.

• Support Historian BO as TE to maintain and improve the Historian system.
• Connect new sensors/devices to automation and control systems, and develop comprehensive automation strategies.
• Manage all project phases from concept and user requirements to commissioning and qualification (IQ/OQ/PQ) in conformity with EU GMP.
• Lead vendor audits and selection teams, recommend vendor/project matches, and manage procurement processes.
• Work with vendors or engineering firms to guide and oversee systems design for facilities.
• Develop estimates, track costs, and manage project schedules.
• Handle project design changes and conduct impact analysis (cost, timing, safety, GMP).
• Manage automation systems anomalies, maintenance, and validation (Configuration Management, Performance Monitoring, Security, and Situational Operation).
• Collaborate with IT, QA, Engineering, and Modernization stakeholders to define requirements and implement automated solutions.
• Manage multiple related projects to ensure alignment with strategic objectives.
• Work creatively and analytically in a problem-solving environment, demonstrating teamwork, innovation, and excellence.
• Define user requirements and translate them into project documents (P&LD, Layout, Data Sheet, Mechanical and Electro-instrumental Work Requisitions).
• Prepare estimates and detailed project plans for all phases.
• Align offers technically and financially for the Purchasing department to proceed with commercial negotiations.
• Define and control the GANTT of assigned projects, ensuring deadlines are met in line with quality requirements.
• Ensure full compliance with Safety and Quality standards in collaboration with HSE and QA departments.
• Program and configure Delta V DCS for new process plants, validate DCS systems, and manage instruments calibration for FDA inspection.
• Finalize and execute Commissioning, Qualification, and Validation (CQV) strategies and plans for all site activities.
• Serve as the point of contact for Teva and the Client for all CQV-related matters.
• Work with the TAPI safety team to ensure safe execution of C&Q operations.
• Be accountable for schedule, costs, and customer quality expectations.

• Engineering Degree

• Objectives focused with excellent planning and organizational ability
• Good communication skills with attitude to work cross-functionally in a complex and variable environment
• Commissioning and validation experience in the pharmaceutical industries required
• Day-by-day high focus together with mid-long term view
• Ability to be customer-focused, self-driven.
• Good attitude to planning and prioritization in alignment with business and customer needs.
• Experience negotiating vendor contracts
• Strong automation design background
• IT systems familiarity
• Fluent English

• 2-3+ years’ experience as Automation Engineer preferably within relevant industrial production environment.
• Project Management involvement in the production and utilities systems.
• Preferred project delivery experience with budget management including capital projects

• Canteen
• Working flexibility for Caregivers and parents
• Coffee Key
• Recognition Program
• Welfare Platform
• Health agreement with medical centers of excellence
• Highly inclusive and multicultural working environment
• Continuous learning and development programs

Santhià (VC), from Monday to Friday

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

In the Manufacturing Science and Technology (MS&T) Department we are looking for a brilliant profile reporting to the Site General Manager with the following responsibilities and activities for Caronno Pertusella (VA) and Villanterio (PV) sites:

• Leads the MS&T group ensuring the necessary technical and scientific support to the manufacturing activities of commercial products aimed at process improvement and problem solving.
• Collaborates with other company functions to ensure the effective management of product manufacturing processes.
• Collaborates with the Research and Development function to ensure robust industrialization/scaling, validation and reliability during the development phase of new product manufacturing processes.
• Participates with other business functions in change management process ensuring that all changes to processes and technologies used in the manufacturing processes of commercial products or the introduction of new processes/technologies are carried out in line with company procedures and in accordance with cGMP requirements.
• Support other company functions in the event of anomalies or deviations in the manufacturing processes of commercial products, ensuring technical and scientific support.
• Lead (along with Production and Operational Excellence) strategies for line optimization, cost reduction, competitiveness improvements, new products introduction and transfer in/out projects.
• Translate site's plan on mentioned projects/initiatives to detailed production schedule in close cooperation with Site SC.
• Ensure workflow optimization and implement processes for manufacturing of new products.
• Understand changes in business needs and transfer into strategy.
• Ensure quality of all manufactured products and maintain environmental regulations and standards.
• Ensure knowledge of Tapi’s strategy, direction and challenges.
• Be familiar with competition, industry trends and technologies to recommend creative and innovative solutions.
• Participate in global project groups.
• Proactively share across the Tapi Network best practices, process improvements and lessons learned.
• Execute product transfers and material changes under function responsibilities.
• Look after the wellbeing safety and health of the workforce.
• Ensure employee’s engagement and motivation to function successfully by fostering a team-based and caring environment and by being visible to all staff.
• Drive employee enablement and ensure proper training is provided to guarantee certified, competent staff to accomplish the required tasks.
• Lead the MS&T management team, track performance and develop talent.
• He/She is an influential member of the site management team.
• Take an active role in promoting cross-site initiatives, teamwork and collaboration across site’s functions.

• Education: Chemistry/Engineering or equivalent; PhD is preferred.
• Ensure Quality Management System is fully in place where applicable in the function and within the area of responsibility maintaining total compliance to current GMP, GDP, Data Integrity requirements.
• Ensure adherence to environment, health and safety company requirements as well as legal obligations.
• Behave according to company Ethical Code and company values.
• At least 3 years of experience in the role
• Managerial skills
• Communication skills
• English and Italian fluent

We try to take care of our employees, offering them small and large benefits. By way of example:

• Ticket Restaurants for each working day
• Working flexibility for Caregivers and parents
• Recognition Program
• Welfare Platform
• Highly inclusive and multicultural working environment
• Continuous learning and development programs (with full access to Linkedin Learning!)

Type of contract: long term contract

Caronno Pertusella (VA) from Monday to Friday with visit to Villanterio (PV)