Hours: 8am-4pm 10am-6pm (Weekly shift rotation)
Job Type: Permanent
* Works closely with manufacturing staff to ensure the unit meets customer expectations on delivery and product quality.
* Responsible for release of product from the system.
* Responsible for supporting production in the review and post compounding check operations.
* Responsible for implementation and management of the companies quality system within the compound unit.
* Ensuring regulatory compliance.
* Ensure that unit is compliant with all corporate quality system policies and procedures.
* Responsible for review of the implementation of the company Quality System to initiate, and drive continuous improvement
1. Post Compounding check and Release
o Responsible for the Review of prescriptions on Merlin
o Responsible for release activities associated with products manufactured at the compounding units.
1. Change Control
o Maintain a local change control process to ensure all changes are fully documented
o Ensuring all changes are assessed for risk and impact prior to implementation
o Ensuring that all changes are completed fully as per impact assessment and in the appropriate time frame
o Management of the site Validation Master Plan
o Ensuring all equipment used for the manufacture and storage of product is validated before use
o Ensuring all equipment used for the manufacture and storage of product is re-validated as required per the validation master plan.
3. GMP and Facilities and Equipment Control
o Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct.
o Responsible for ensuring the schedule of microbiological monitoring ensures the product is safe to use, including ensuring a schedule and facility map are in place and that all testing is complete
o Investigation of out of limits results using exception and CAPA processes
o Ensuring all measuring equipment that may have an impact on product quality are calibrated to traceable standards
4. Quality System Measurement and Review
o Ensure outcomes, decisions and actions of the review are documented
o Ensure meeting actions are completed to agreed deadlines
o Track and trend on a monthly basis quality system data and indicators, including but not limited to Exceptions, Errors and Complaints. Trending should include timeliness in completion as well as actual numbers
o Ensures all incidents reported by customers are appropriately documented and investigated
o Management of complaints using TW8
o Responsible for reporting any complaints that may result in Field Corrective Action immediately to the Business management representative and also the European FCA gatekeeper
8. Audit Management
o Ensures that the facility is always ready for an internal, corporate, MHRA or 3rd party audit
o Manages the audit process for the facility, organization of the management team and staff to ensure a successful audit
o Ensuring that audit findings are fully investigated to find root cause and that actions to address the audit findings are carried out in a timely manner to address the issue
9. Communication and Training
o Regularly communicates with all site staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance
Breadth & Depth of experience 2 years experience of working in a aseptic compounding operation
12 months experience of quality system implementation
Field of expertise: Ideally experience in all or any of the following:
Quality system management and implementation
Environmental / microbiological control
If you are interested in this position or would like to hear more information then please call Daniel on 0208 364 9911. Alternatively you can email me on firstname.lastname@example.org
We act as an employment business to provide temporary staff and an employment agency to provide permanent staff.