Validation specialist

Exciting Opportunity in Pharmaceutical Organization

We are seeking a talented individual to join our team at an award-winning pharmaceutical organization based in Cork. As one of the leading multinationals in the industry, we offer a challenging and rewarding career path.

Duties:

* Develop and implement validation strategies, coordinate with external vendors, write protocols independently, submit samples, analyze test results and prepare technical reports.
* Execute business activities such as equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
* Provide support during 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 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 and present as an SME on relevant topics during regulatory inspections.
* Ensure compliance with site EHS policy, cGMP and other business regulations and 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.

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.

About Us:

We are an award-winning pharmaceutical organization committed to delivering high-quality products and services. If you are looking for a challenging and rewarding career, please consider joining our team.