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.
Independent compliance function within HSE focused on the development and implementation of an internal audit methodology to monitor and report on management system capability and effectiveness. Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and assesses and reports on how requirements are being met. Supports regulatory audits and new license applications.
- To develop and implement a Chemical Hazard Risk Control program.
- To drive the development and implementation of the associated strategic plans and supporting initiatives necessary to realize the Corporate Commitment to Safety Excellence.
- Define and guarantee the maintenance of a corporate Chemical Risk Assessment process to standardize cross site assessment of chemical exposure risk.
- Define and coordinate the process of Categorization/OEL development and reporting to support manufacturing and new business opportunities and define and monitor the repository of approved categorizations.
- Liaison with the Business Development Team, the Client and Manufacturing to ensure categorization alignment and communication.
- Define and guarantee the communication of containment verification standards and support sites in containment verification activities.
- To provide functional direction and support to the site HSE Specialists on the assessment of Occupational Hygiene Risks and to coach and support site HSE Specialists.
- To be a technical leader advising and influencing the strategic safety technical needs of individual sites and supporting site strategies for new technology implementation or facility development.
- To provide expert technical leadership and consulting to global operations with a focus on identifying Occupational Hygiene safety related hazards, compliance obligations, the assessment of risks, and with assisting sites in implementing compliant technical solutions.
- To develop Occupational Hygiene Training Requirements and support training activities.
- To Monitor Performance and to provide support as necessary to achieve the standards of performance required.
- To provide support to all Occupational Hygiene functional improvement activities (e.g., training, tools, work processes, auditing, metrics, internal programs, and standards.
- To secure and leverage senior level commitment and support for the integration of good Occupational Hygiene practices and considerations into short and long-range business, capital and operations planning.
- To collaborate with cross functional site & corporate teams (business development, plant management, engineering, supply chain, utilities) to implement HSE capability projects.
- To drive cross site engagement and knowledge sharing relating to HSE initiative and projects.
- To monitoring emerging trends, programs and issues, and to communicate and educate others on process safety topics.
- Prepare and propose for approval the annual Occupational Hygiene & Toxicology budget, by defining the allocation of resources necessary for the development of the activity, as well as ensuring the monitoring and control of its evolution, identifying any deviations between the real and the foreseen and taking corrective measures.
- Ensure 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) within his/ her TMs.
- To support and contribute to the objectives and functioning of the CHSE team.
- To assure and promote compliance on Health, Safety, Environment and Sustainability, including the prevention of major accidents hazards, by exercising good governance and through the implementation of policy, procedures and training.
- Master´s degree in Safety, Chemistry, Engineering, or related field
- Professional Certificate in Occupational Health and Safety at work (desired)
Technical background preferred
- Typically requires 10 years of relevant experience in HSE in a cGMP environment and coordinating a team.
- Proven leadership experience
- A proven track record operating in a HSE role in a pharmaceutical/chemical manufacturing environment required
- Effective time management skills and the ability to multitask
- Track record of overachieving targets
- Possess extensive knowledge of occupational hygiene and toxicology principles and practices, and is able to lead others on them
- Advanced knowledge of compliance needs in occupation hygiene, toxicology and GMP
- Advanced knowledge and broad-based understanding of operations within a chemical / pharmaceutical manufacturing environment allied to a deep understanding of the risks posed by those operations to the safety of personnel and the environment
- Must have the Knowledge, Experience and Skills to ensure that the requirements necessary for the Control of Major Accident Hazards are being fully implemented
- Strong awareness, knowledge and understanding of the HSE regulatory environment
- Strong understanding of the operating principles and safety features of pharmaceutical processing technologies
- Familiarity with regulatory compliance procedures, publications and an ability to interpret relevant legislation
- Good communication skills (verbal and written)
- Skilled at driving processes and tools
- Fluency in English (mandatory)
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down
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.
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