We are seeking a skilled professional to join our Pharmaceutical organization based in Carlow.
Job Summary
This is an excellent opportunity for individuals who want to work with a leading multinational company that excels in its field. The successful candidate will be responsible for executing cleaning cycle development and performing equipment qualification (PQ). They will also be involved in writing and adhering to validation strategies, coordinating with external vendors, and preparing technical reports.
Key Responsibilities
* Execute business activities, such as equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
* Support the commissioning phase by reviewing and approving documents, ensuring they comply with standards.
* Participate in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
* Prepare technical reports and perform statistical analysis of data.
* Adhere to the latest regulatory guidelines.
* Represent the IPT on cross-functional project teams.
* Provide technical input and support, presenting as an SME on relevant topics during regulatory inspections.
* Ensure compliance with site EHS policy, cGMP, and other business regulations, supporting 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.
Requirements
* 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 GxP systems associated with this role, including GLIMS and eVAL, electronic batch records.
Estimated Salary:
$60,000 - $80,000 per annum, depending on experience.