Title: Senior QA Officer
Location: Hampton, London, UK
Touchlight Ltd has established a high-quality DNA manufacturing platform using novel in vitro processes. Owing to our continued growth and success an exciting opportunity has arisen in our new DNA Services Division for a suitable applicant.
The successful applicant will play an important role in maintaining compliance of our quality systems and with Good Manufacturing Practices. This is an operational quality role working alongside many departments in the company. The role is within our Quality Assurance department as part of the wider Quality Unit.
Key systems in Quality Assurance will include; Quality Events and Deviations, CAPAs, Root Cause Analysis, Risk Assessments, Self-inspections, Internal and External Auditing, Batch Review, Validation and Qualification, Change Control, Training, Data Integrity, Document Control, Complaints and Continuous Improvement initiatives.
- Strong IT skills; competent Word, Excel and PowerPoint skills
- Good communication skills both verbal and written
- Ability to act as a mentor to junior staff
- An extremely organised and conscientious approach to tasks
- Ability to prioritise multiple tasks
- Confidence to challenge and simplify existing systems & processes
- Reliable, enthusiastic and self-motivated
- Experience of completing documentation with a high degree of accuracy
- Excellent communication skills are required with external clients
- The ideal candidate will have a Degree level qualification in a biological science discipline
- Strong knowledge of working within a GMP and/or GLP environment
- Strong knowledge of Quality Management Systems
- Experience in co-ordinating validation and qualification programs
- Experience with quality event management and CAPA programs
- Experience of change control procedures
- Experience in handling complaints, returns and recall
- Experience in quality risk management, root cause analysis and FMEA processes
- Working knowledge of regulatory requirements
- Working towards a Qualified Internal and External Auditor status
- Experience in hosting regulatory and customer audits
- Knowledge of approaches to data integrity
- Ability to challenge data quality for release purposes
- Developing Continuous improvement initiatives
- Experience of self-inspection and Internal auditing programs
This is an exciting opportunity to join a young dynamic biotech company working at the forefront of DNA manufacture. In addition to receiving a competitive salary and performance related bonuses, the successful candidate will be invited to join the company pension scheme.
Apply for this role by emailing a CV and tailored cover letter (in pdf format) to email@example.com clearly stating the reference "Senior QA Officer".
Candidates must be able to work in the UK.