NOTICE
Location - Central London, London
Salary -£45,000
Company -Cpl Life Sciences
Job type -Permanent
Key Accountabilities
Maintenance of the UK and Ireland Quality Management System (QMS):
Ensuring that local quality release of batches of a medicinal product for the UK & Ireland markets is performed in an accurate and timely manner and in compliance with regulatory requirements
Ensure compliance with Global and Local Quality principles, standards, policies, and SOPs
Track operational Quality and Compliance
Issuance of all documents used within the QMS, including maintenance and control of local SOPs, including alerting SOP owners of SOP review dates, tracking updates to the SOPs, performance of gap assessments between global and local procedures in a timely manner
Author, review, and approve SOPs as required
In cooperation with other team members, prepare periodic Quality reports
Review, process, track and close out Change Controls/Deviations/Risk Assessments, including liaising with relevant Heads of Department to perform root cause analysis and to discuss and agree on CAPAs
Support and facilitate the roll-out of Global Electronic Document/Learning/Quality Management Systems as required by the business
Ensure all personnel receives the necessary training via the e-learning systems and that training delivered follows Global standards:
Ensure training matrix is in place for relevant staff with responsibilities defined within the QMS and documented appropriately
Assist with the performance of Quality inductions for all new starters
Assign relevant SOP training to all staff (including service providers) and ensure that training records are kept using the e-learning system
Education, Skill, and Experience
BSc in a scientific discipline.
Experiences working in a quality department or with managing quality-related documentation (such as standard operating procedures) in another related function, such as Pharmacovigilance, Compliance or Finance
Experience of writing and updating SOPs with clarity, accuracy, and rigor
Knowledge of GDP requirements
Experience of working within electronic quality and document management systems
Experience of working with Enterprise resource planning (ERP) systems
Excellent organizational, planning and time management skills.
Computer literate, including Adobe Acrobat and Microsoft Word/Excel.
Excellent attention to detail.
Can effectively prioritise and manage multiple competing tasks and demands
Appreciates and advocates the importance of being compliant and maintaining compliance records
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