My client a leading Pharmaceutical company now require a QC Analytical Services Supervisor to join their rapidly expanding team.
The QC Analytical Services Supervisor is responsible for the implementation and management of laboratory systems to support the manufacture of a new Biologics product in a start-up laboratory.
QC Analytical Services Supervisor
- To develop and maintain required documents, including SOPs, specifications, and forms for all QC computerised systems, in conjunction with QC Manager \ Head of Quality or designees.
- To facilitate dialogue\support between the LIMS/Empower vendors and the system users, to troubleshoot and resolve issues.
- Implement and validate test methods for the Cell Therapy Manufacturing Facility.
- To execute and review validation and data migration within protocols and reports
- The loading of LIMS Static Data for all test methods
- LIMS data management and maintenance
- Integration of all laboratory equipment and associated software to LIMS
- Contribute effectively to the design and implementation of quality systems in the Cell Therapy QC laboratories to comply with relevant current regulatory expectations.
- To identify and support the implementation of functional area end-user requirements and enhancements.
- To deliver LIMS/Empower system training as appropriate to users and\or the functional area, and to maintain adequate records.
- To identify report requirements for functional areas, to design\develop or assist in design\development of reports.
- To provide support to other business systems with respect to the interface with LIMS/Empower, to assist in developing instrument integration and data acquisition.
- To assist in validation activities (IQ, OQ, PQ) as required, coordinating and\or executing various portions of system validation, for example performance qualification.
- To ensure the system static data is updated in a timely manner to ensure compliance.
- To work in conjunction with the LIMS/Empower users to ensure compliance across all user groups.
- To liaise with QC, QA, IT and Manufacturing Operations departments in the performance of normal duties.
- To carry out the investigation into any non-conformance, accident or other abnormal occurrence
- Implement and maintain standards of safety to ensure a safe working laboratory.
- Support major projects, quality initiatives and continuous improvement programmes within the QC department(s) and in other functional areas
- To highlight and where necessary implement new technologies in QC area.
- Ensure data integrity guidelines are implemented and adhered to, for QC based systems.
- Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
- Implementing efficiency improvements in Quality Department on a continuous basis and participating in site projects and initiatives.
- Communication and liaison with other Analytical Services Executives in sister laboratories.
- Communication and liaison with Laboratory End Users on issues, providing guidance and support to others.
QC Analytical Services Supervisor
- Minimum of 5 years’ experience in the pharmaceutical/Biologics industry.
- Minimum of a BSc Degree (life science)
- Practical experience working in a GMP laboratory
- Practical experience working with LIMS as data input or reviewer
- Working with Labware Version 6 is preferred but not essential
- Experience of in the manufacture Biologics and aseptic manufacturing
- Experienced in technical writing
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below