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Overview: PM Group is currently looking for a Cleaning Validation Specialist to join a client side project in the greater Cork area. The role involves providing validation and technical support to the Vaccines production team, specifically in cleaning cycle development and cleaning validation.
Responsibilities:
1. Execute cleaning cycle development, cleaning validation, and PQ of equipment.
2. Write and adhere to validation strategies, coordinate with outside vendors, write protocols independently, submit samples, analyze test results, and prepare technical reports.
3. Execute run-the-business activities including equipment periodic reviews, cleaning periodic reviews, CAPAs and deviations, change control, and risk assessments.
4. Provide support during the commissioning phase by reviewing and approving documents.
5. Ensure documentation complies with standards.
6. Participate in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
7. Write technical reports and perform statistical analysis of data.
8. Adhere to the latest regulatory guidelines.
9. Represent the IPT on cross-functional project teams and provide technical input and support during regulatory inspections.
10. Ensure compliance with the highest standards for Quality and Safety.
11. Comply with site EHS policy, cGMP, and other business regulations.
12. Support Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations.
13. Participate and comply with our Manufacturing Division Quality Management System (QMS) requirements.
Qualifications:
1. 3-5 years’ experience as a validation specialist in a pharmaceutical or highly regulated environment.
2. B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field.
3. Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
4. A working knowledge of the GxP systems associated with this role would be advantageous, including but not limited to: GLIMS and eVAL, electronic batch records.
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