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Maintenance Planner & Validation Specialist

Date: Nov 13, 2022

Location: Caronno Pertusella, IT, 0000

Company: Teva Pharmaceuticals

Who are we

 

Teva, world leader with over 40.000 employees, in the field of equivalent medicines, with a differentiated business that also includes specialist medicines, over-the-counter drugs and the production and marketing of APIs (active pharmaceutical ingredients), is present in Italy for over 25 years with a commercial branch and manufacturing sites.
Our mission is simple: improve the wellbeing of our patients.
We care about them and about our colleagues, creating a respectful, diverse and inclusive working environment, committing ourselves to maintaining high standards of quality, compliance and safety, always respecting our values:


Teva Code of conduct


We all work for one company and we work together to achieve a common goal.

Reporting to

 

Site Engineering Head

Main activities and responsibilities

 

  • Define the validation study features, such as sampling, testing, or analytical methodologies.
  • Define the direct validation activities, such as protocol creation or testing.
  • Collaborate with other departments like QA, MS&T, Production to develop validation master plans, process flow diagrams, test cases, or standard operating procedures. 
  • Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.
  • Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
  • Support audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
  • Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
  • Identify deviations from established product or process standards and provide recommendations for resolving deviations.
  • Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
  • Manage and drive the supplier in the validation activities of the new or existing equipment.
  • Resolve testing problems by modifying testing methods or revising test objectives and standards.
  • Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
  • Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
  • Communicate with regulatory agencies regarding compliance documentation or validation results.
  • Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
  • Maintain validation test equipment.
  • Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
  • Validate or characterize sustainable or environmentally friendly products, using electronic testing platforms.
  • Analyse the machine history data and equipment status included deviations, CCM and perform the periodic annual review of equipment and of the utilities.
  • Support the Maintenance Manager to review the preventive maintenance plan based on the results of equipment validation or the periodic annual review of equipments and utilities.
  • Analyse and conduct risk assessments supporting the Engineering projects. 
  • Support the Maintenance manager to update the preventive maintenance plan on Priority system.

Requirements

 

Essential requirements:

 

  • Priority and Trackwise system knowledge and management.
  • Quality Management System knowledge (GMP, GDP, Data Integrity) and duly application in all activities performed.
  • Knowledge of Environment, Health and Safety principles and applicable main EHS local regulations.
  • Full compliance with TEVA Ethic Code and Values.

 

Education:


Technical High School degree.

 

Languages:     

 

Fluent English.

 

Skills:

 

  • Excellent planning and organizational ability
  • Attitude to work cross-functionally in a complex and variable environment
  • Precision and accuracy
  • IT systems familiarity
  • Relevant Priority knowledge

What we offer?

 

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

 

  • Recognition Program
  • Health insurance
  • Ticket restaurant 
  • Welfare platform
  • Health agreement 

 

Type of contract: long term contract from January 2023.

Department

 

Engineering

Location and working program

 

Both sites Caronno Pertusella (VA) and Villanterio (PV) from monday to friday.

Teva's commitment to equal opportunities

 

Teva is committed to equal opportunities in the world of work. Our global policy requires equal employment opportunities to be provided regardless of age, race, religion, health, identity or gender expression, or any other legally recognized status that is entitled to protection under applicable laws.