Overview
We’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
* Execute cleaning cycle development and PQ of equipment.
* Write and adhere to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
* Execute business activities such as equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, and risk assessments.
* Provide support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards.
* Participate in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
* Technical report writing and statistical analysis of data.
* Adhere to the latest regulatory guidelines.
* Represent the IPT on cross-functional project teams.
* Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
* Adhere to the highest standards for Compliance (Quality and Safety).
* Ensure compliance with site EHS policy, cGMP and other business regulations; support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
* Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
Education & Experience
* Experience as a validation specialist in a pharmaceutical or highly regulated environment and a B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or a related field.
* Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
* A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS and eVAL, electronic batch records.
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.
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