Process and Cleaning Validation Manager

Process and Cleaning Validation Manager

Teva

Milan, Italy

Job purpose

  • Ensure that the principles of process performance qualification (PPQ) are applied in compliance with the cGMP, which ensure a high level of quality in the manufacture of pharmaceutical productions;
  • Lead PPQ activities with support of all involved functions for current and new products/processes;
  • Response for cleaning validation for all on-site technologies;
  • Maintain the cleaning program per applicable agency requirements;
  • Responsible for the revalidation of existing products that underwent changes which warrant the product to be revalidated;
  • Responsible for any remediation program related to current and legacy processes, advise with R&D and work with site to make any necessary changes;
  • Lead the validation activities for all process improvements, equipment changes scale-up and scale down, introduction of alternate APIs, process changes, device changes and any other technical decisions made during the lifecycle of an existing product;
  • Ensure the implementation of standard operating procedures relating to MS&T activities in compliance with cGMP requirements;
  • Ensure the process is performing within acceptable parameters of the original validated status and is robust by looking statistical trends in the data;
  • Responsible for the implementation of a Continued Process verification program to ensure process robustness, identification of process remediation/improvement related to critical process parameters and optimization (i.e lyophilization cycles, step yield, etc.

Main activities and responsibilities

  • Ensure, through a validation/qualification process, that a given pharmaceutical production is carried out in a uniform, consistent and repeatable manner, with reference to the specified specifications, to Pharmacopoeia and cGMP standards;
  • Identify the variables and critical points of a production process of the main pharmaceutical forms and equipment used in production processes;
  • Check the impact of the introduction of new products on the cleaning state of the production equipment;
  • Revise protocols for all validation activities involving the plant by applying the above described development;
  • Keep up-to-date on competencies by comparing with what is constantly under development;
  • Coordinate and manage validation and revalidation tests;
  • Perform function training activity;
  • Establish the frequencies of re-validations, verifying the implementation and issuing a conclusive approval on all activities;
  • It is able to apply risk analysis - "risk assessment" - in the activities of the industry;
  • Managing the industry by proposing synergies between the various groups leading to simplification and rationalization of the activities;
  • Comply with the directives received, controls its execution and exercises an environmental, safety and health initiative in accordance with UNI EN ISO 14001, OHSAS 18001 and Legislative Decree 81/2008 art. 19 "Responsibilities of the person in charge", within the scope of the function;
  • Coordinate and manage the team of expertise who, using statistical tools:
    • support the resolution of manufacturing issues;
    • troubleshoot existing problematic products utilizing robustness tools and recommend scientific resolution to problems;
    • evaluate the process capability of the critical quality attributes to ensure the product is robust;
    • provide insight and expertise to assess feasibility and address challenges to formulation, scale up and related product and process changes;
    • support failure investigations for product quality issues to identify root cause, propose remediation.
  • Within the relative department, implements the directives received, monitors its implementation and has a power of iniziative in the field of environment, safety and health provided by the UNI EN ISO 14001, OHSAS 18001 and Legislative Decree 81/2008 art 19 “Obligations in charge to the Preposto”

Qualifications

Education

  • 2nd level Degree (MSc) in Pharmaceutical field (Pharmacy, Chemical and Pharmaceutical Technology, Biotechnology) or Engineering.

Skills

  • High knowledge of pharmaceutical production, knowledge and awareness of GMP;
  • High knowledge of pharmaceutical world and production processes (complex products, large molecules, biologic products);
  • High knowledge of manufacturing technologies related to formulation, aseptic filling, lyophilisation, packaging and serialization;
  • Process planning and optimization capabilities;
  • Monitoring / Implementation of Established Plans;
  • Analytical, decision-making capability and problem solving skills.

Languages

  • Proven fluent English;
  • Minimum Experience/Training required;
  • At least 10 years in the Pharmaceutical field in technical roles.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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