Senior Qualific & Validation Specialist

at  Hovione

Join a Market Leader:
Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.
Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.
Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.
You will be responsible to::

Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.

• Assure cGMP compliance in the activities related to Qualification and Validation of systems/equipment, utilities and facilities, throughout their lifecycle
• Coach/train Sites’ Quality and Operational areas, promoting a culture of continuous improvement standards in such a way as to guarantee the fulfilment of latest applicable regulations
• Promote the Qualification and Validation vision and energize less experienced team members to provide an outstanding service
• Review and proposed changes to the required corporate procedures that regulates Qualification and Validation activities to align and harmonize with associated disciplines/ areas (e.g.: preventive maintenance, calibration, Engineering, Digital (Automation/IT), Quality Control, when applicable, etc.)
• Guarantee the fulfilment of the applicable Quality and Regulation requirements in all projects under own responsibility
• Assure a Risk based approach in the Qualification and Validation related activities
• Answer and give guidance on Qualification and Validation subjects to Client and Health Authorities’ requests
• Participate in Conceptual, Basic and Detailed design review for Projects of each Hovione ‘s Site, and any major Projects for Corporate functions, in order to assure the GMP
• Compliance against applicable Guidelines
• Plan and/or establish Qualification and Validation requirements for each project
• Establish the required qualification activities of new or changed systems and/or facilities within the change control process
• Prepare/approve VMP of Projects of each Site, approve the VMP for major Projects and support Project’s execution at each Site, for Corporate functions
• Approve (pre and pro execution) Qualification and Validation protocols as well as Final VMP Report (for major Projects) and other systems’ related documentation such as Periodic
• Review Reports, at Site level Participates or support internal or external/customer audits and health authority inspections
• Control/close/approve deviations, CAPA, improvement plans, and change control related to Qualification and Validation of Systems Master Qualification and Validation processes and tools
• Manage complex projects/ analysis with significant impact on business
• Make quality and timely decisions based on multiple sources of data
• Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
• Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
• Promote the importance of management through the applicability of LEAN tools and others considered relevant for the area objectives
• Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)

We are looking to recruit a Candidate::

• University, or equivalent, qualification in Chemistry, Chemical Engineering, Mechanical Engineering or similar scientific field (mandatory)
• Typically requires 5-8 years of relevant experience in Quality and Qualification and Validation in industry environment
• Advanced knowledge of Quality, Engineering, cGMP, ICH and ISO guidelines, Risk Assessment applied to Qualification and Validation and LEAN 6-Sigma with the ability to solve complex problems
• Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
• Fluency in English is a requirement
• Computer literate with good working knowledge of the MS Office package

• Assure cGMP compliance in the activities related to Qualification and Validation of systems/equipment, utilities and facilities, throughout their lifecycle
• Coach/train Sites’ Quality and Operational areas, promoting a culture of continuous improvement standards in such a way as to guarantee the fulfilment of latest applicable regulations
• Promote the Qualification and Validation vision and energize less experienced team members to provide an outstanding service
• Review and proposed changes to the required corporate procedures that regulates Qualification and Validation activities to align and harmonize with associated disciplines/ areas (e.g.: preventive maintenance, calibration, Engineering, Digital (Automation/IT), Quality Control, when applicable, etc.)
• Guarantee the fulfilment of the applicable Quality and Regulation requirements in all projects under own responsibility
• Assure a Risk based approach in the Qualification and Validation related activities
• Answer and give guidance on Qualification and Validation subjects to Client and Health Authorities’ requests
• Participate in Conceptual, Basic and Detailed design review for Projects of each Hovione ‘s Site, and any major Projects for Corporate functions, in order to assure the GMP
• Compliance against applicable Guidelines
• Plan and/or establish Qualification and Validation requirements for each project
• Establish the required qualification activities of new or changed systems and/or facilities within the change control process
• Prepare/approve VMP of Projects of each Site, approve the VMP for major Projects and support Project’s execution at each Site, for Corporate functions
• Approve (pre and pro execution) Qualification and Validation protocols as well as Final VMP Report (for major Projects) and other systems’ related documentation such as Periodic
• Review Reports, at Site level Participates or support internal or external/customer audits and health authority inspections
• Control/close/approve deviations, CAPA, improvement plans, and change control related to Qualification and Validation of Systems Master Qualification and Validation processes and tools
• Manage complex projects/ analysis with significant impact on business
• Make quality and timely decisions based on multiple sources of data
• Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
• Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
• Promote the importance of management through the applicability of LEAN tools and others considered relevant for the area objectives
• Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others