To support the effective implementation and maintenance of the Quality System in compliance with current Good Manufacturing Practice, Good Clinical Practice and the MicroPharm quality strategy.
Duties and Responsibilities:
* Ensure Quality Systems are maintained in compliance with regulations and MicroPharm standards, and applicable to the operation and integrated within the PQS.
* Report performance metrics and KPIs identifying compliance and performance issues/risks, drawing conclusions and making recommendations to management.
* 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.
Qualifications and Experience Required:
* Degree in a scientific discipline preferable.
* A minimum of one years’ experience in a similar role within the pharmaceutical or allied industry with a sound knowledge of the regulatory requirements is desirable.
Skills & Attributes
* Strong IT skills including MS Word, Excel and PowerPoint.
* Competent, highly organised individual capable of working independently and effectively to pre-defined timelines.
* 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 self-motivated 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.
In return for your commitment, enthusiasm and drive, we offer:
* Opportunities to learn and develop – MicroPharm is a world leader in antivenom manufacture.
* Contributory workplace pension.
* Income Protection (on successful completion of probation)
* Life Assurance (on successful completion of probation)
* 33 days holiday inclusive of Bank Holidays.
* Employee Assistance Programme (EAP).
* Free on-site parking
Remuneration:
£25,000 to £29,000 dependent on experience
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