Job responsibilities
The postholder duties include:
Quality Control
Manage the day-to-day operation of the laboratory to provide a safe, high quality, efficient service.
Assign resource to fulfil customer requirements based on priorities, adjusting as necessary.
Ensure all required consumables, reagents and standards are available for all laboratory activities.
Ensure appropriate specifications are in place for all components, materials, and products. Where available these should be aligned with Pharmacopeial monographs.
Implement and maintain a system of pharmacopeial review to ensure compliance with the latest updates.
Ensure up-to-date records for raw material assessments are maintained, ensuring compliance with relevant requirements including (but not limited to), Good Manufacturing Practice (GMP), TSE (Transmissible Spongiform Encephalopathies) and Nitrosamines.
Assist in the evaluation of new raw materials, whether these are additional sources, alternative grades, or novel.
Ensure test methods are appropriately validated and documented.
Review and dispositioning of components and raw materials.
Oversight of retained/retention samples process including collection, storage, retrieval, and destruction.
Oversight of the Out of Specification (OOS) process ensuring identification, documentation, investigation, and remediation is appropriately actioned.
Provide expertise in assessment and investigation of laboratory issues (including complex OOS investigations), applying appropriate use of Risk Management Principles and Root Cause Analysis tools.
Conduct self-inspection audits as part of the internal auditing team and in line with the audit schedule.
Owner of the Laboratory Information Management System (LIMS).
Provide assistance in the assessment and investigation of complex Customer Complaints as QC Subject Matter Expert.
Oversight of Environmental Monitoring including trending.
Oversight of Water for Injections monitoring including trending.
Oversight of Contract Laboratories ensuring service levels are maintained.
Audit of prospective contract laboratories and routine re-audit of approved contract laboratories as required.
Review and approval of documents, reports and procedures appropriate to the role.
Monitoring of KPIs relating to the Laboratory, highlighting non-compliance and trends, identifying areas of improvement, and implementing remedial actions as appropriate
Projects
Support projects within HPS as Subject Matter Expert as required.
Lead and deliver minor projects (including the purchase of new equipment) specifically related to QC and associated activities.
Quality and Compliance
Ensure all QC activities are carried out in accordance with the principles of cGxPs in order that the quality and compliance requirements are met.
Ensure all laboratory equipment is qualified, calibrated and maintained.
Operate within the Quality Management System including:
o Change Control
o OOS, Deviations and investigations
o CAPAs
Owner of relevant SOPs and responsible for their accuracy, review, update and implementation, ensuring compliance with latest regulatory expectations.
Follow defined SOPs relating to all aspects of work.
Maintain accurate records aligned with ALCOA+ principles.
Participate in inspections and audits as Subject Matter Expert.
Ensures that the data integrity requirements for GxP are complied with during all aspects of work.
Ensure retention and archiving of QC records (including data back-up) are done in accordance with regulations and HPS policy.
Health, Safety and Environment
Ensures that Health and Safety and COSHH regulations relating to quality control activities are adhered to.
Manual Handling of equipment, parts and materials is done in accordance with good practice.
Continuous Improvement
Identify and implement continuous improvement of systems, processes and equipment, taking into account advances in technology and best practice. Note continuous improvement could be related to quality, efficiency, customer satisfaction, culture or cost.
Clinical Duties
There are no clinical duties required in this post.
This role is deemed to provide a basic clinical technical service indirectly to patients in the manufacturing and delivery of medicines.
Professional Duties
Maintain a working competence in all areas of responsibility and to exercise the knowledge and skill that can be reasonably expected based on the role and any relevant qualifications.
Operate professionally and impartially.
Declare and avoid any potential conflicts of interest created by the post.
Managerial Duties
Direct line manager responsibilities for QC team including:
Holiday approval and oversight
Appraisals and Personal Development
Absence and performance management
Training and competency
Direction and prioritisation of workload for the team.
Recruitment of team members.
Chair QC meetings
Monitor and report relevant KPIs, ensuring targets are being achieved and implementing remedial actions where necessary.
Manage budget costs relating to functional area and projects.
Financial Duties
Responsible for the installation, repair and maintenance of QC equipment and systems.
Managing Self
Participate in regular supervision.
Attend all mandatory training.
Participate in appraisal at least annually identifying, developing, and agreeing your own development plan with your Line Manager using the Trust Appraisal.
Comply with all Trust policies, procedures, and protocols.
Carry out duties with due regard to the Trusts Equal Opportunity Policy.
Seek advice and support from Line Manager whenever necessary.
Maintain professional conduct always including appearance.
Exhibit the values and behaviours expected by the Trust as part of One Culture of Care
