Validation Specialist
- NI & Ireland
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
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.
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We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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Janis
I manage this role.