An amazing opportunity has arisen for an Instrument Validation Specialist with a pharmaceutical company in Tipperary. The position offers the opportunity to work with a team of professionals in a modern analytical laboratory using the most up to date technology and quality assurance procedures. The laboratory operates under Lean principles and employees the use of a wide variety of analytical techniques
- Sourcing and procurement of Analytical Laboratory instrumentation.
- Responsible for the execution of the yearly Laboratory Capital Equipment Installation plan.
- Responsible for the generation and completion of SDLC Validation documentation for new equipment and COTS based computerised system introduced to the site.
- Maintaining Analytical Laboratory instrumentation in validated state to support testing activities in accordance with site schedules and company policies, procedures and guidelines.
- Support the introduction of new technology and instrumentation to the site with a focus on Data Integrity principles.
- Responsible for the decommissioning of all equipment as appropriate.
- Be part of a dynamic team responsible for Data Integrity requirements for all computerised and non-computerised systems across all the laboratories.
- Aid in the resolution of issues that may arise during laboratory instrument qualification and use.
- Participate in assigned improvement projects.
Qualifications & Experience:
- Degree in Science (Chemistry, Physics or related Life Science) and/or relevant experience.
- Knowledge of GMP standards.
- Have knowledge Laboratory safety standards.
- Must have good communication skills, both written and verbal.
- Strong documentation skills are required.
- Must be motivated, focused and technically strong.
- To perform instrument maintenance and troubleshooting.
- To maintain accurate records in compliance with GMP expectations.
- To understand and internalise procedures relevant to GMP operations.
- Technical lab skills (precision, etc).
- Communication – written, oral.
- Team and interpersonal skills.
To apply for this job email your details to firstname.lastname@example.org.