Job Title: Qualified Person.
Roles and Responsibilities:
- Ensure compliance with cGMP, corporate standards/Clients Quality Systems, site policies/procedures, regulatory requirements, and industry standards.
- Maintaining awareness of Quality Management Review and Annual Product Review reports, relevant deviations, CAPAs, change controls, Regulatory Authority Inspections and Product Complaints and the use of unlicensed drug components.
- Participate in cross functional teams as required to provide consultative support of quality related issues. Provides support with investigations and resolution of discrepancies. Assures completeness in terms of root cause, action taken and CAPA.
- Perform investigation of customer complaints / quality defects.
- Coordination and Performance of corrective and preventive action investigations (CAPA's)
- Ensure that operational instructional documentation (SOPs and batch documentation) are up to date, complaint, and supports production.
- Liaising with the Batch releasers responsible for product release.
- Responsible for reviewing production and batch records for completeness and releasing product.
- Perform quality review of orders prior to manufacture.
- Liaising with Dispatch and customer service to manage quality issues and timely customer service.
- QA approval of environmental monitoring results and trends.
Merlin Manufacturing System and Stability:
- Maintenance of Merlin Component Files, Finished Product Codes and review of drug admixture stability and assignment of shelf-lives.
- Facilitate, review, update and maintaining stability data on the system when required and in accordance to the annual stability review schedule.
Changes/New Projects/Periodic Reviews:
- Support the introduction of new products and review and approve qualification/verification protocols/reports, procedures, specification, validation deviations and project validaton/plans as required.
- Support release of equipment, utilities, facilities, and computer systems following the execution of test protocols.
- Key member of Quality Risk Management and Operational Excellence to improve efficiencies and to promote continuous improvement. Identify and implement continuous improvement opportunities.
- Ensure that change controls are compliant with applicable procedures and that it does not inadvertently alter the validated state of a process/product.
- Awareness of complaint and quality defect investigations.
- Utilize both Global and local system for management, investigation and reporting of customer complaints.
- Ensure all complaints are closed within specified timeframes.
- Ensure inspection readiness in work completed.
- Carryout cGMP compliance area walk-throughs of manufacturing as required ensuring site is always audit ready. Maintain visibility on Production and Processing floors and perform spot checks on product and documentation.
- Assist in the internal and external audit program. Participate in regulatory and corporate/internal audits. Conduct audits as per internal audit schedule.
- Review and approve internal audit reports.
- Manage and maintain the Documentation System.
- Review and approval of Quality documentation.
Quality System Management and Review:
- Responsible for the completion of the Quality Management Review meetings and the Annual Product Quality Review.
- Ensure outcomes, decisions and actions of the review are documented.
- Ensure meeting actions are completed to agreed deadlines.
- QP Qualification.
- Pharmacy Degree (or equivalent) in science-related discipline essential.
- Previous experience in Pharmaceutical company or equivalent-type role. Ideally a minimum of two years' experience in a GMP regulated aseptic environment.
- Experience/qualifications in microbiology/environmental monitoring a distinct advantage.
- Working in a project based environment would be advantageous.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.