Quality Assurance Associate Temporary role

Job Description

Quality Assurance Associate - Temporary roleThe role will be at least until the end of December 2021.Currently working remotely.You will be part of the QA team dealing with batch releases and customer complaints.Working hours:Monday to Thursday: 08:00-16:45Friday:08:00-13:00Client DetailsThe client is a large pharmaceuticals manufacturer with multiple sites in the UK.The QA team is currently working from home and in normal circumstances is office based, working closely with supply chain.DescriptionQuality Assurance Associate - Temporary roleThe role holder is responsible for working cross-functionally and reviewing and compiling batch specific documentation and data for batch release, ensuring compliance with licensed and cGMP requirements, escalation of potential issues, and timely submission of LRPs/release of batches in order to meet supply demands. The role holder is also responsible for completion and on time closure of PTC/deviation investigations, ensuring potential trends are identified and escalated, robust investigations performed, appropriate CAPAs implemented. A key aspect is to provide quality support and oversight to other functions and projects as defined by the quality assurance manager, working cross-functionally, and instilling and promoting a quality culture.To work with other QA colleagues to ensure that batch specific documentation and data, including batch release packs and lot release protocols, are reviewed and compiled for QA Manager/QP release. Ensuring compliance with licensed and cGMP requirements, identification and resolution/escalation of issues that may impact submission/release, and timely release of batches in order to meet strict supply demands. To ensure that other team objectives are achieved and to monitor this progress, suggest and support execution of required work, and suggest and implement improvements.To perform PTC /AE activities, as required, to ensure root cause investigations are completed in a timely manner and critical items are escalated to management.To have an active involvement in site quality systems, deviations, change controls, SOPs and self-inspections. Actively maintain and promote a cGMP compliant culture, ensuring the highest standards of Housekeeping and Safety are applied in the team, in accordance with current regulations and procedures. To be permanently inspection ready, ensuring that the review, storage and archive of cGMP documentation and batch specific records is up to date and at the required standards.To participate in improvement project teams, where required, driving quality decisions and providing advice and technical support, where required. Coordinate completion of any resulting activities. Demonstrate creative problem solving within cGMP constraints and align with best practice.Profile*Knowledge of cGMP regulations and background in the Pharmaceuticals industry* Experience dealing with batch release & customer complaints* Proven time management skills for planning and schedule of work* Proven Communication skills both written and verbal* Ability to work as a member of a team, but flexible to work on their own* General experience of Quality Management Systems* Computer Literate* Fluency in English* Graduate level in relevant discipline or suitable alternative or equivalent experience within industry* SAP experience is desirableJob Offer

Quality Assurance Associate - Temporary role - Near Liverpool

Competitive hourly rate

Can work remotely

Sociable, engaging, and supportive team

Early finish on Fridays

Required skills

Quality Assurance Associate - Temporary role

Keyskills :
Quality Assurance Associate - Tempary role