Senior Validation Specialist
- BBBH788034 Sep 27, 2021 Competitive
I am working with a large Pharmaceutical company who are seeking a Senior Validation Specialist to join their growing team in Dublin on a permanent capacity.
Key responsibilities for this role:
- Leading and executing Qualification and validation strategies for key site processes including packaging and manufacturing and on-going process validation, in line with current regulatory requirements, corporate policies and site procedures, including the generation/review of validation documentation
- Presenting qualifications during internal and external audits.
- Ensuring validation is maintained for site equipment, systems, and utilities, including providing validation input for site Change Controls.
- Executing site periodic reviews and revalidation activities for processes
- Perform validation functional testing as required. Track and resolve deviations during qualification activities.
- Perform gap analysis on the site procedures for areas of responsibility against current regulations and corporate policies and adapt site policies/SOPs to comply with latest regulatory and corporate expectations.
- Perform review activities of Validation Specialist documentation.
- To participate in the site change control system affecting pharmaceutical products and medical devices, ensuring that all changes to validated processes and systems are introduced in a formalised manner.
- Bachelor's degree in Science, Engineering, Technology, or a related discipline.
- Relevant experience as a validation engineer/specialist in a cGMP environment, preferably in an OSD facility.
- Effective technical writing skills.
- Excellent trouble-shooting and problem-solving skills
- Ability to work as part of a team and on your own initiative in a constructive manner.
- Must take ownership of all tasks assigned and proactively see them through to conclusion.
If this role if of interest click 'apply now'.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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