Quality Assurance Specialists
Location: Essex Contract: Permanent Pay Rate: Competitive Salary + Excellent Benefits Do you have experience working in a GMP Quality Assurance role?
Would you like to work for a cutting-edge company working across modern Biological Therapeutics such as Gene Therapy and Cell Therapy?
My client, based in Essex have several Quality Assurance positions available across various departments including New Product Introduction, Audits, Batch Review and Documentation Control.
The successful candidates will be reporting to the Quality Assurance Lead to ensure that the facility, via proactive engagement, meets the standards and expectations of all key stakeholders, the regulatory authorities, potential clients and all internal/external stakeholders. You will be responsible for supporting the maintenance and continued development and improvement of the Quality Management System and monitoring performance against agreed key performance indicators.
Due to the nature of the departments responsibilities/requirements will vary, but we expect individuals to meet most of the following criteria:
- Educated to Degree level in a life sciences discipline with several years' Quality Assurance experience in a Phase III / commercial pharmaceutical manufacturing of biologicals, vaccines, cell or gene therapies manufacturing facility.
- Experience in Quality Management Systems such as Q-Pulse or Trackwise
- Experience with QMS documentation processes, including GMP document control, Deviation Management, Corrective & Preventive Action (CAPA), Change Control, Risk Management, Customer Complaints
- Experience in review of batch related and non-batch related documentation
- Proven record of supporting of quality operations and manage multiple activities concurrently as roles are within high volume, complex areas.
- Knowledge of EU / MHRA and FDA regulatory environments (desirable but not mandatory)
- Excellent written/oral communication skills, interpersonal relationship building and team working skills.
- Ability to demonstrate clear, reliable & timely decision making skills.
- Demonstrable written and verbal communication skills
Key Words: "Corrective & Preventive Action (CAPA), QMS, Quality Management System, batch review, audits, Q-Pulse, Trackwise, change control, deviation, customer complaints, quality assurance"
This is an excellent opportunity for someone to forge a career in cutting edge science, within a renowned business in Essex.
Please apply online or call Umul Ahmed on 0203 0964529.
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