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”
2nd level Degree (MSc) in Pharmaceutical field (Pharmacy, Chemical and Pharmaceutical Technology, Biotechnology) or Engineering.
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.
Proven fluent English;
Minimum Experience/Training required;
At least 10 years in the Pharmaceutical field in technical roles.