QA Officer - Newcastle Emlyn, United Kingdom - JK Recruitment

JK Recruitment

Verified Company

Newcastle Emlyn, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Position Objective

To support the effective implementation and maintenance of the Quality System in compliance with current Good Manufacturing Practice, Good Clinical Practice and the quality strategy.

Duties & Responsibilities

Act as a Quality System Stream Lead, ensuring that:
the system is maintained in compliance with regulations and company standards, and is applicable to the operation and integrated within the PQS;

- clearly written procedures are established and system users are suitably qualified through requirement definition and training provision;
- implementation issues are identified and reported to management;
- performance metrics and KPI are reported, identifying compliance and performance issues/risks, drawing conclusions and making recommendations to management;
- needs for performance improvement are identified and independently interacts with users, championing permanent solutions;
- maintains current industry knowledge and acts as a Subject Matter Expert.

Review, check and approve completed batch and associated quality documentation to ensure compliance with GxP prior to certification by the Qualified Person.
Perform internal and support external audits and complete all follow up actions including report writing.
Perform and support investigations as they relate to deviations, complaints and adverse events to ensure the identification of true root cause and implementation of SMART and effective Corrective and Preventive Actions (CAPA).
Support the generation, review and completion of Change Controls, ensuring scope of change is clear and implementation actions are robust and completed in a timely manner.
Manage and collate information for Product Quality Reviews.
Support regulatory and customer inspections.
Provide intra/interdepartmental training as required.
Prepare, review and approve Standard Operating Procedures and other Quality documents.

Qualifications & Experience Required

Degree in a scientific discipline preferable.
A minimum of one years' experience in a similar role within the pharmaceutical industry with a sound knowledge of the regulatory requirements.
Strong IT skills including MS Word, Excel and PowerPoint.

Skills & Attributes

Competent, highly organised individual capable of working independently and effectively in a highpressure environment.
Creative thinker who questions the status quo and proposes innovative solutions to complex problems.
Pays strict attention to detail and has the ability to analyse data and detect trends.
Highly selfmotivated and directed individual who operates with a pragmatic and calm manner.
Strong written and oral communication skills with the ability to influence and negotiate effectively.

Salary:
£25,000.00-£26,000.00 per year

Schedule: