The role of QC Stability Supervisor is to manage a team of analysts and provide guidance, support, coaching and mentoring to deliver a best in class stability program. The role involves ensuring the correct procedures are adhered to in order to comply with GMP, Health and Safety, SOP's for both environmental and regulatory requirements.
Location: Onsite in our Loughrea laboratory (5 days per week).
As QC Stability Supervisor your key responsibilities are as follows:
* 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 the testing of stability finished product formulations for analysis as per stability study ensuring the testing are carried out as per the approved study protocol
* Responsible for real time stability testing of stability study sample within the study window period within Quality Control Department in close co-operation with commercial batch testing Supervisor.
* Ensuring Reference standards, reagents, chemicals, HPLC/UPLC/GC columns are made available for analysis and stock is maintained in required quantity. Liaise with Lab technician and lab administrators to act promptly in ordering consumables required for testing.
* 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
* Management and completion of Deviations, OOS/OOT investigations, LIRs; to its conclusion with sound scientific justification to meet the HPRA and EU regulations and communicate promptly to QP's and Quality Assurance team and QC manger. Implement corrective actions to prevent re-occurrences.
* 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 QC Manager.
Education Experience:
* Bachelor's degree in a science-based discipline.
* Minimum of 5 years of relevant experience in a pharmaceutical environment.
* People management experience with the ability to lead and motivate a team.
* Experience working within a pharmaceutical cGMP environment, with knowledge of EU GMP.
Skills Competencies:
* Strong computer skills, particularly in Microsoft Office.
* Strong organizational skills, time management skills, and the ability to prioritize competing demands.
* People management experience with the ability to lead and motivate a team.
* Strong technical skills and working knowledge of the most common analytical techniques and relevant software.
* Strong adherence to ALCOA+ data integrity principles.
* Ability to build relationships and collaborate effectively with others.
* Excellent communication skills, both verbal and written.
* Strong analytical ability and problem-solving skills.
* Flexible and willing to learn and develop new technical people skills.
Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.