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This is an chance to work for an industry leading pharmaceutical company that invests heavily in Research and Development and produce life changing drugs.
The role of the Validation Specialist would include:
- Developing and maintaining the site Validation Master Plan.
- Driving completion of cleaning and sterilization cycle validation activities.
- Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and revalidation.
- Develop post OQ documentation in line with the company’s and regulatory requirements.
- Authoring and reviewing standard operating procedures and technical reports.
- Supporting global regulatory submissions as needed.
- Applying LeanSixSigma in the Validation group by:
- Securing continuity of an appropriate LSS/CEM level of knowledge.
- Facilitate problem solving & risk assessment (FMEA) projects
- Experience with upstream cell culture and/or downstream purification of biological molecules.
- Technical operations experience in the drug substance manufacture of biological molecules at the pilot- and/or commercial-scale.
- Temperature Mapping Experience.
- Cleaning Validation Experience.
- Autoclave Experience.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
Our Partner in Tipperary area develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which
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