Job Summary
This is an exciting opportunity to join a leading multinational pharmaceutical organization based in Cork. We are seeking a skilled professional to execute various business activities and provide technical support.
Key Responsibilities
2. Execute routine business activities such as equipment periodic reviews, cleaning periodic review, CAPAs, deviations, change control, risk assessments.
3. Provide support during the commissioning phase by reviewing and approving documents to ensure compliance with standards.
4. Participate in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
5. Write technical reports and perform statistical analysis of data.
6. Adhere to the latest regulatory guidelines.
7. Represent the IPT on cross-functional project teams.
8. Provide technical input and support, and present as a subject matter expert on relevant topics during regulatory inspections.
9. Ensure adherence to highest standards for Compliance (Quality and Safety).
10. E nsure compliance with site EHS policy, cGMP, and other business regulations, and support Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations.
11. E nsure 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 would be advantageous, including GLIMS and eVAL, electronic batch records.
About Us
We are a leading multinational pharmaceutical organization based in Cork, committed to delivering high-quality products and services.