The purpose of this role is to provide chemistry expertise in delivering technical projects for the Technical Shared Service group.
- Provides chemistry element of the prioritised process improvement projects
- Provides chemistry element of the prioritised 2nd generation improvement projects
- Provides technical support to product transfers into/out of non-NPI sites and 3rd party sites
- Supports other groups in a matrix managed environment to support delivery of network priorities
- Supports and helps define knowledge management standards for chemistry in the network
- Read and understand all relevant Quality Management System documents and Operating Procedures relevant to your job role.
- Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements to ensure cGMP standards are maintained
- Participate fully in our quality initiatives and attend training and complete assessments as required.
- Read and understand the EHS Systems documents and Operating Procedures relevant to your job role.
- Ensure risk assessments, risk communication and action planning are completed in accordance with our Risk Management System (RMS)
- Ensure that all incidents and accidents are reported to determine root cause and that any subsequent CAPA’s are closed out in a timely manner.
- Lead by example to demonstrate the right EHS behaviours and encourage others to improve our safety culture
- Proven experience in working within multidisciplinary teams in support of API manufacturing to achieve successful delivery of projects
- Proven ability to engage, negotiate with and influence managers and stakeholders across discipline, functional and geographical boundaries
- Self-starter with strong self-management skills
- Excellent communication skills
- Capability to assess and meet customer demands to create effective business solutions
- Proven ability to drive for and deliver results – SLA focus
- Demonstrated ability to think critically and innovatively combined with willingness to challenge
- Proven resilience skills in a previous role
- Demonstration of the use of OE and other investigative and business tools that supports embedding of an OE culture – at least OE Advocate trained
- Strong technical skills. Must be a graduate in chemistry and/or a demonstrated track record in the Pharmaceutical Industry in a technical role. (PhD or masters in organic chemistry preferable)
- Demonstrated excellent laboratory skills including working knowledge of EHS, GMP and Quality standards
- Self-sufficient in key analytical methods ie. HPLC & NMR
- Strong technical knowledge depth in all aspects of API support from laboratory through to plant application with considerable experience in process development, DoE & process scale up.
- Proficient in organic synthesis and demonstrated ability in solving complex problems
- Excellent presentation & report writing skills
- Awareness of statistics and its application
- Awareness of process engineering and its application eg. Unit operations, compatibility, control, commissioning
- Understanding of key strategic technologies and their application to API manufacture and understanding of where their application can deliver business benefit
- Developing knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9) for API
- Knowledge of core secondary unit operations
- Knowledge of consumer healthcare function
For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email firstname.lastname@example.org
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