Quality & Laboratory Manager
Location: South East England
Do you have experience in quality assurance in a biopharma, biomedical or other biological laboratory?
My client is an exciting company specialising in the retrieval and long term storage of stem cells. They are now seeking a Quality & Laboratory Manager who would be responsible for QA, QC, and laboratory management. The role encompasses overseeing the QMS ensuring compliances including the HTA, GMP, GLP and ISO13485, as well as managing a stem cell processing laboratory and GMP manufacturing facility.
Overview of Key Duties and Responsibilities:
* Oversee the Quality management system to ensure it supports all applicable regulations and standards
* Foster a site wide culture of quality and continuous improvement
* Responsible for internal and external audit programs, regulatory inspections and CAPA
* Develop and direct quality improvements
* Designated Individual for HTA license and Responsible Person for the MHRA
* Ensure GLP, GMP, and ISO13485 compliance
* Maintain and review laboratory and manufacturing procedures to ensure compliance with current legislation
* Responsible for the ongoing validation of laboratory and manufacturing processes, machines and materials
* Supervise training and work of laboratory and manufacturing staff and critically assess for compliance
* Management of laboratory and manufacturing staff
To be considered for this opportunity, you must have the following skills and experience;
* Experience of overseeing quality operations within a biopharma, bio services or biosciences related environment is essential
* Proven laboratory experience in a similar environment
* Strong experience of GMP, GLP, ISO13485 standards essential
* Experience of HTA and EUTCD regulations essential
* Cleanroom / aseptic technique is essential
* Good communication skills (Written and verbal)
* Ability to prioritise work of own and others, and work on own initiative
Key words " Lab Management, quality control, quality assurance, Quality Manager, Laboratory Manager, Biobank, Stem cell, Mammalian cell culture, Biomedical, QA, Human tissue Authority, HTA, EUTCD, ISO13485 "
Please apply online or call Neil Walton on 0203 096 4706
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.
You must be eligible to work in the UK. Learn more
- Agency: SRG
- Posted: 13th March 2018
- Expires: 10th April 2018
- Reference: J25854