This company provides access to high quality medicines for millions of people worldwide.
Make a Difference
Each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help:
• Responsible for writing, executing & reporting of all validation activities including but not limited to (VP/ DQ / FAT / IQ / OQ / PQ / PPQ / pFMEA).
• Validation/Qualification projects will be across a range of production areas which may include, Equipment Qualification (Lyophilisers, Autoclaves, Filling Lines etc), Product Processes, Cleaning, Computerised Systems, Utilities and associated Capital projects.
• Act as a subject matter expert in process validation which will be performed against Corporate SOP/HPRA /FDA/EMEA requirements.
• Generation, execution and close out of validation projects relating to existing products and new product introductions.
• Participates in project teams and assists in determining project schedules and the relevance of appropriate levels of validation.
• Statistical analysis of data to determine process capability.
• Execution and documenting of process risk assessment / failure mode and effects analysis.
• Track and resolve exceptions during qualification activities.
• Represent validation at internal and external audit.
Make Our Values Your Values
Our client hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:
• Minimum of a Diploma in a Science/ Engineering or related discipline and 2-4 years’ experience in a Technical/QA/ Validation Role within the pharmaceutical industry or a similar operating environment with in-depth knowledge of validation processes.
• Experience in statistical analysis techniques and process validation will be considered a distinct advantage.
• Must process knowledge of Pharmaceutical Manufacturing Programs
• Must possess strong project management and organizational skills. Self-motivation and drive.
• Excellent interpersonal, communication (written & oral) & technical report writing skills.
• Must be flexible and able to manage multiple priorities simultaneously.
• Must be an active learner and have a positive leadership attitude.
• Proficiency in speaking, comprehending, reading and writing English is required.
If you would like further Information you can contact the recruiter directly:
Kevin Silke | Tel: +353 (0) 1 507 9255