1.To ensure complaint and timely compilation of validation protocols and reports, ensuring adherence to planned completion dates
-To liaise with all departments to obtain the required information for inclusion in validation protocols and reports.
-To submit protocols for review and approval against the planned approval dates
-To maintain the library of validation documentation and supporting documentation and ensure they are compliant with relevant SOPs and standards
-Prepare and submit any required samples for additional testing to QC and any 3rd party companies
-To ensure appropriate standards of cGMP, housekeeping, Health, Safety and Environment are applied in accordance with current regulations and site procedures.
-To ensure that the review, storage and archive of validation records and other relevant GMP documentation is up to date and at the required cGMP standards.
-To maintain and update validation documentation tracker
-Support documentation related process improvements and projects.
-Provide a professional, timely, responsive service to requests from other departments for routine activities, issue resolution and training.
Validation Protocols & reports to be submitted in line with planned dates.
Liaison with cross functional departments where appropriate.
Good interpersonal, communication and team working skills are required. Time management, diplomacy and the ability to work under pressure are also essential. A positive, flexible and pro-active approach to work is required. Attention to detail is key
Internal Stakeholders - Representatives of all site departments and particularly Quality Organisation Management
External Stakeholders - third party manufacturer representatives, vendors and suppliers
Work schedule prioritisation decisions required to deliver protocols according to plan.
Innovation and ideas expected in association with own work processes
-Knowledge, Skills & Competencies
The role holder will possess all or most of the following:
-Experience of working within a cGMP environment
-Excellent attention to detail
-Competent IT skills, particularly MS Excel and Word
-Ability to deliver work according to a defined plan
-Excellent communication skills.
-Ability to work as a member of a team, but flexible to work on their own.
- Minimum Education Requirements
Minimum 5 GCSEs A* -C
-Minimum Experience Requirements
Previous cGMP knowledge an advantage.
Competent in use of Microsoft Word and Excel
Adecco is acting as an Employment Business in relation to this vacancy. The Adecco Group UK & Ireland is an Equal Opportunities Employer.