Quality Assurance Officer - Egham, United Kingdom - Finiten

Description

As one of our clients' Senior Quality Assurance (QA) Officers you will provide vital QA support and experience to our Operations teams in the UK, Malta and Switzerland allowing them to optimise the performance of their respective Quality Management Systems.

You will supplement existing GDP knowledge with additional GMP expertise, allowing the consolidated team to strengthen its GMDP capabilities and reducing the dependency on external service providers.

• Ensure day-to-day QA activities across the Essential Pharma business entities are performed to assure compliance
• Proactivity to ensure that the company is in a permanent state of inspectionreadiness
• Support the RP/RPi and Director QA with all functions needed for the smooth running of such functions, liaising with the RPs in other regions to harmonise systems wherever possible.
• Reduce the dependency on third parties, by internalising QA functions and tapering workload away from contract service providers
• Ensure that the performance of the quality management systems in each business entity is optimised by monitoring the timely execution of change controls, deviations, risk assessments and CAPA
• Gather Quality performance data and identify systematic improvements to implement that will improve KPIs
• Support the wider QA team by conducting duties when colleagues are on annual leave
• Selfinspection assist the RP to conduct selfinspections and creating the documents
• Ensure that adequate records are always maintained and inspectionready
• Recalls assist the RPs with the recall process, including mock recalls
• Customer, Supplier and Subcontractor bona fides ensure initial and periodic qualifications are undertaken
• Assist in carrying out annual reviews of partners
• Complaints monitor (Quality and Distribution) by ensuring that the complaints are logged, updated and completed compliantly
• Trending assist in performing trends for distribution complaints, product complaints (internal and external), deviations and returns
• Gather and interpret data for continual review, and for reporting at the Quality Forum and Quality Management Review
• Assist with waste uplift and destruction of samples
• Support the QA function in performing audits of suppliers andpartners
• Provide periodic QA training to colleagues and the wider team, in both GMP and GDP requirements
• Review Product Quality Reviews provided by contract manufacturing organisations, assessing trends and opportunities for improvement
• Reviewing CoA/CoCs, stability data and samples
• Carry out any other tasks deemed necessary by the manager/company

• Life science degree; including pharmacy, chemistry or other equivalent qualification required.

• Previous experience in equivalent roles, such as a pharmaceutical quality assurance role within a manufacturing setting
• Demonstrable understanding of GxP including GMP
• Experience of having carried out, or been exposed to, the key activities/responsibilities listed above

• Strong agile thinker who can adapt to situations of highspeed change
• Must demonstrate integrity and high ethical standards with good attention to detail
• Passionate about Quality, enthusiastic about continuous improvement and dedicated to the achievement of compliance
• Problem solver who can work through complex issues and offer creatively compliant solutions
• Previous demonstration of working effectively as part of team with strong collaboration
• Demonstrates a willingness to achieve goals together and respect the view of others
• Results and deadline orientated with a cando mentality, and accountable for own actions

• Company car
• Life insurance
• Private medical insurance

• Monday to Friday

• Performance bonus