Join a Market LeaderHovione 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,utilitiesand facilities, throughout theirlifecycle
- Coach/train Sites' Qualityand Operational areas, promoting a culture of continuous improvement standards in such a way as to guarantee the fulfilment of latest applicableregulations
- Promote the Qualification and Validation vision and energizeless experiencedteam members to providean outstandingservice
- Review and proposed changes tothe required corporate procedures that regulates Qualification and Validation activitiesto align and harmonize withassociated 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 projectsunder ownresponsibility
- Assure a Risk based approach in the Qualification and Validation relatedactivities
- Answerand give guidance on Qualification and Validation subjects to Client and Health Authorities'requests
- Participate in Conceptual,Basicand 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 applicableGuidelines
- Plan and/or establish Qualification and Validation requirements for eachproject
- Establish the required qualification activities of new or changed systems and/or facilities within the change controlprocess
- 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/approvedeviations, 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 onbusiness
- Make quality and timely decisions based on multiple sources ofdata
- Manage risk and uncertainty; anticipate and escalate roadblocksin order toprevent deviations to thegoals
- 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 areaobjectives
- 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,systemsand 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
Hovione is a proud Equal Opportunity Employer Inclusion and diversity are key to us.
At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect.
We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.
#J-18808-Ljbffr