Validation Expert
4 days ago
This is an exceptional opportunity to work with a renowned Pharmaceutical organization in Cork, Ireland. The successful candidate will be responsible for executing various tasks to ensure compliance with industry standards.
Key Responsibilities:- Execute cycle development, cleaning validation, and performance qualification of equipment.
- Develop and adhere to validation strategies, collaborate with external vendors, write protocols independently, submit samples, analyze test results, and prepare technical reports.
- Execute routine 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 compliance with industry standards.
- Participate in cross-functional problem-solving teams for troubleshooting and investigations within the Vaccines IPT.
- Prepare technical reports, perform statistical analysis of data.
- Adhere to the latest regulatory guidelines.
- Represent the IPT on cross-functional project teams.
- Provide technical input and support, present as an SME on relevant topics during regulatory inspections.
- Ensure adherence to 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.
- 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.
For more information about this opportunity, please contact us directly.
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