Job Title: Validation Specialist
We are seeking a highly skilled Validation Specialist to join our Pharmaceutical organization in Carlow.
This is an excellent opportunity for individuals who want to work with a leading multinational company that excels in its industry.
* Develop and implement cleaning cycle validation and perform equipment qualification.
* Collaborate with vendors, write protocols, submit samples, analyze test results, and create technical reports.
* Execute business activities such as equipment periodic reviews, cleaning periodic review, CAPAs, deviations, change control, risk assessments.
* Support commissioning phase by reviewing and approving documents to ensure compliance with standards.
* Participate in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
* Write technical reports, conduct statistical analysis of data.
* Maintain adherence to the latest regulatory guidelines.
* Represent the IPT on cross-functional project teams.
* Provide technical input, support, and present as an SME on relevant topics during regulatory inspections.
* Maintain highest standards for Compliance (Quality and Safety).
* Ensure site EHS policy, cGMP, and other business regulations compliance, and support Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations.
* Promote Quality, Compliance, and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements.
Requirements:
* Experience as a validation specialist in a pharmaceutical or highly regulated environment, with 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, manufacturing, or Process Engineering.
* A working knowledge of GxP systems associated with this role, including GLIMS and eVAL, electronic batch records.