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QC Validation Technical Specialist

HertfordshirePermanent
Experience Dependent
Job Reference: J5634647
Updated On: 17/03/2021
Status: Now Interviewing
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Biotechnology, Contract Research Organisation, Contract Manufacturing Organisation, Life Sciences, Bioprocessing

Skills: Project Management - Technical PM, Project Management - Scientific PM, Quality Assurance - GMP, Quality Assurance - Validation, Quality Assurance - Documentation, Validation - Equipment Validation

Job Information

Role Overview

Are you an experienced QC Validation Technical Specialist looking for an exciting new job opportunity?

We are currently looking for a QC Validation Specialist to join a leading biopharmaceutical company based in the Hertfordshire area.

As the QC Validation Specialist you will support the laboratory by providing specialist knowledge and problem-solving ability for all analytical techniques, problematic results, and validation requirements across the section and working as the subject matter lead.

Key Duties and Responsibilities

Your duties as the QC Validation Specialist will be varied however the key duties and responsibilities are as follows:

1. You will be responsible for planning your own validation activities as well as activities for the Quality laboratories, ensuring delivery on timelines. You will also support the progression of Minor and Major deviations, provide technical support for critical deviations and support site driven investigations and improvements.

2. You will lead the departmental OE initiatives, empowering staff to identify improvements. Reviewing and approving improvements, enabling staff to deliver for leaner ways of working and act as an SME for QC validation, providing the training and support for inexperienced member of staff to increase their knowledge/ability in validation activities.

3. As the QC Validation Specialist you will be responsible for training staff in validation activities, identify and validation new QC equipment, adhere to ICH guidelines for analytical method validation and also lead technology transfer and validation projects.

4. Additionally, you will also participate with the receipt of audits from internal and external sources and assist with the implementation of internal policies, following cGMP guidelines.

Role Requirements

To be successful in your application to this exciting opportunity as the QC Validation Specialist we are looking to identify the following on your profile and past history:

1. A Degree in a relevant subject and significant experience in a regulated GMP/GLP laboratory environment, with a focus on technical knowledge of methods as well as experience in QC equipment validation is essential for this role.

2. The following are also essential for the role of QC Validation Specialist; experience of raising, completing, and investigating quality records, project management experience, knowledge of industry guidelines and experience of writing protocols and reports.

3. A biochemist or experience working in the biopharmaceutical industry would be highly advantageous for this position.
Debra Fong
Your Recruitment ConsultantDebra Fongdebra.fong@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.