The 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.
To perform training required for own role and keep own training records up to date.
To cross-train in activities which will allow contribution and support to activities in other QO departments, as required by the business
And other job duties that may be assigned from time to time.
J. Knowledge, Skills & Competencies
What critical knowledge, competencies (as well as professional certifications and licenses) are needed to successfully perform this position (e.g., PC/technology skills, sales experience, demonstrated leadership, specific educational requirement or technical training, etc.)?
* Knowledge of cGMP regulations and background in the Pharmaceutical industry
* 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
Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.
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