This is a fantastic opportunity to join a leading Pharmaceutical Company based in the North West who are seeking a Quality Assurance Officer on a permanent basis.
Salary - £22,000 - £23,000
Describe the main purpose of the job:
To develop, implement, audit and maintain the Quality System according to the requirements of International Standards and GMP requirements.
To identify, measure, control and improve the various quality business processes that will lead to improved business performance.
Main responsibilities:
Responsible for all aspects of the company quality systems in compliance with EU/ICH Guidelines
Develop, implement and review company quality system procedures and practices
Manage and maintain the Deviation & CAPA system, effective trending and timelines of actions for closure
Work with process/document owners to determine and implement actions to reduce the occurrence/ re-occurrence of non-conformities
Support the progress of failure/quality investigations and CAPAs
Prepare, execute and monitor the annual self inspection schedule
Manage and maintain the internal audit system to both local procedures and expectations of EU/ICH Guidelines
Ensure areas audit readiness
Support Supplier Audits, where appropriate
Ensure all actions to address internal/external/regulatory audit findings are realistic, timely and fully owned and that progress is confirmed and reported
Actively participate during Regulatory audits
Ensure compliance with all Documented Quality Systems and EU requirements during day-to-day and assigned audit/Deviation/CAPA activities
Develop, implement and coordinate the stability programme for all products
Develop stability program policies and procedures
Perform trend analysis and monitoring of stability data
Initiate stability studies & create study protocols & reports
Initiate alert reports & communicate product stability information to all applicable parties
Responsible for the qualification/calibration, operation and maintenance of the stability cabinets
Lead, motivate and develop the Stability team, ensuring that the team is properly resourced, appropriately skilled and operate professionally, effectively and efficiently
Generate Product Quality Reviews (PQR) for all products
Communicate any adverse findings from the product reviews to all relevant parties
Oversee the Quality Document Department to ensure accurate and streamlined activity is maintained on Change Control activity
Support the Customer Complaint system
Maintain a knowledge of activities through regular contact with Senior Management
Meet objectives set and carry out any other duties as directed by the Qualified Person
Specific professional/technical expertise and experience required for the job:
Scientific education background (e.g. B.Sc. in Chemistry or related subject).
Background in cGMPs (awareness of ISO would also be advantageous)
Experience of auditing against cGMPs and ISO 9000 series is advantageous
Objectively and accurately interpret data and express findings in a clear and concise manner.
Background in MS Office
Ability and initiative to work independently and as part of a team.
Willingness to travel
Salary:
£22- £23k + Benefits
QUALITY ASSURANCE
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