To provide guidance, support, coaching and mentoring to QC Staff in carrying out analytical testing ensuring the correct procedures are adhered to in order to comply with GMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring we meet our customer’s needs.
Responsible for the day to day management of the stability group and analysis
To provide technical support as required by management
- Co-ordinate and manage the on site stability programme at CPML.
- Co-ordinate the stability programme in Chanelle Lab Jordan relating to the CPML site.
- Liaising with customers as the need arises
- Assisting in internal and external audits
- Problem solving and team management.
- Responsible for putting corrective actions in place and ensuring ongoing compliance with customer specifications and Chanelle QMS
- Assessing and delivering product specifications and customer requirements
- Actively promote best practice in quality methods and continuous improvement.
- Ensure all process documentation is fully auditable i.e. that it is prepared, updated and filed in accordance with all Regulatory guidelines.
- Provide project leadership to ensure effective planning and timely execution of all process improvements.
- Provide technical advice and support to other departments in relation to investigations.
- Update of site quality system with recommendations for improvement where appropriate.
- Ensure adherence to all relevant Standard Operating Procedures (SOP’s), Calibration and Operation Instructions (COI’s) and existing test methods with reference to pharmacopoeia’s, specifications, regulations and industry standards
- Scheduling of stability analysis, prioritising work in consultation with quality, production and planning in order to achieve an efficient QC/stability system.
- Ensure full analysis of finished product and contract manufactured products are performed in a timely manner and in accordance with approved test methods, schedules and customer requirements.
- Ensure stability testing, method transfer and protocols are accurately completed on a timely basis as per GMP/ICH guidelines
- Ensure product requiring external analysis is accurately documented, despatched and a certificate of analysis received in a timely manner
- On-going monitoring of external laboratories
- Approval of analytical reports, obtaining and reviewing certificates of analysis (where appropriate) and approval of material
- Ensure trend analysis is completed as per GMP requirements
- Ensure stability protocols and reports are completed as per GMP requirements in a timely manner
- To bring to the attention of the Head of Quality any discrepancies, deviations, OOS, OOT or non conformances in testing or work practice.
- Ensure completion of OOS investigations, follow up and implement corrective actions in a timely manner
- Monitoring of OOS and deviations for trend development, highlighting and implementing areas for improvement
- Display proven ability in troubleshooting and problem solving, supporting analyst’s/trainee’s.
- Selection and recruitment of QC analytical staff in conjunction with QC Manager/HR
- Training of new personnel in the receipt and analysis of finished product/stability samples, ensuring all personnel are fully trained prior to analysis
- Ensure a training plan is prepared for each member of the Stability group and training records are maintained and kept up to date at all times.
- Review all laboratory notebooks, records, chromatograms etc. to an acceptable GLP standard and up to date at all times
- Liaising with other team leaders/supervisor/manager and production such that timely feedback of all queries, reporting of results and approval of product is achieved in accordance with their requirements
- Review and update of existing quality procedures/systems while also highlighting, preparing and implementing new quality procedures/systems such that the quality system can be continuously improved
- Ensure records pertaining to Stability are all kept up to date and filed.
- Performance monitoring of the Stability staff.
- Benchmarking of the company’s technical capability against external best practice
- Any other duties as assigned by the Head of Quality.
- Bachelors Degree in related discipline
- 5+ years of Team Leader experience, demonstrated strong change skills & excellent people management.
- Pharmaceutical Laboratory experience is essential
- Proven success in leading a Laboratory, including experience with inspections (FDA and HPRA).