Cache of job #14150401

Job Title

Instrument Validation Specialist

Employer

PROCHEM Engineering Limited

Location

Tipperary

Description

Role Summary An amazing opportunity has arisen for an Instrument Validation Specialist at our client’s pharmaceutical facility based in Co. Tipperary. The Analytical Development and Commercialisation (ADC) department is responsible for all analytical support to the site. This involves testing of raw materials, Excipients,  Components, intermediates, Drug Substance and Drug product. The successful candidate reports to the Laboratory Systems Lead. 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 employs the use of a wide variety of analytical techniques.  Core Duties and Responsibilities: Souring 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.  Minimum Qualifications and Experience:  Degree in Science (Chemistry, Physics or related Life Science) and/or relevant experience. Have 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. Team and interpersonal skills.  To Apply If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us: 14 Danville Business Park, Kilkenny, Ireland. +353 56 77 90100. recruitment@prochem.ie. Click here to submit your CV. Please note, we do not require agency assistance with this role.  .

Date Added

28 days ago

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