Job Title: Validation and Qualification Expert
Job Type: Full-time, Permanent Position.
The successful candidate will be responsible for ensuring that electronic systems within the Quality Control Laboratory and the Quality Systems operate in accordance with the requirements of the departmental Standard Operating Procedures.
This role involves ensuring compliance with current GMP and Corporate expectations, providing input to the review and writing of any associated quality policies, systems and procedures as required, and supporting the effective management of the administration of QC laboratory system applications.
Key Responsibilities:
* Ensure EML's Electronic TrackWise Quality Management System (QMS) and Quality Control Laboratory systems and software used to support the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and Corporate expectations.
* Provide input to the review and writing of any associated quality policies, systems and procedures as required.
* Support the effective management of the administration of QC laboratory system applications providing independence of access for administrator activities.
* Perform Qualification and Validation of EML equipment, processes, systems in line with EML procedures, GMP and GAMP guidelines for process, equipment and electronic systems, as and when required.
* Ensure the maintenance of EML procedures supporting Qualification and Validation ensuring they are current with updated requirements for Qualification and Validation and cGMP, cGxP expectations.
* To act as a Quality Subject Matter Expert in relation to ensure compliance of Qualification, Validation and all CSV activities within EML control.
Requirements/Qualifications:
* Ability to understand and analyse user requirements to facilitate changes and system improvements.
* Proficient knowledge of electronic systems, CSV and GAMP requirements.
* Good understanding of the requirements of data integrity and application to system management.
* Good understanding of Quality Control Systems and analytical software and electronic Quality Systems.
* Ability to interpret complex data and present key findings.
* Ability to describe technical information in easy-to-understand terms.
* Good understanding of GMP Guidelines and Regulations.
* Knowledge of the qualification and validation requirements for equipment and electronic systems.
* Maintain knowledge and understanding of technical advancements in electronic systems.