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Details
Validation Specialist
Reference: | SMC48605 | Location: |
Cork |
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Validation Engineer
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
- Execute cycle development, cleaning validation and PQ of equipment.
- Writing and adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
- Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
- Provide support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards.
- Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
- Technical report writing, statistical analysis of data
- Adherence 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.
- Adherence to highest standards for Compliance (Quality and Safety)
- 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.
Education & Experience
- Experience as a validation specialist in a pharmaceutical or a 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.
Medical Affairs Laboratory Scientist Cork Biopharmaceutical IT Scientist Medical Device Connected Health Validation Engineer Scientific Quality Control Quality Assurance Sales and Marketing Chemistry Biotechnology Academic Quality Engineering Product Development Engineer Packaging Engineer Microbiology Cork City Diagnostics Mayo Life Science Project Manager Sales and Marketing Academic Dublin Supply Chain Manufacturing Executive Supply Chain Allied Healthcare Pharmaceutical Limerick Pharma Sales PhD Clinical Research Engineering
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS