A fantastic opportunity for a QC Chemistry Specialsit to join a leading pharmaceutical company within Athlone to support with an ongoing project. The successful candidate will be competent in HPLC analysis and the necessay troubleshooting, Empower and paperbased data review.
The QC Chemistry Specialist performs sampling and testing of raw material, in-process materials, finished and stability products. The Specialist will be heavily involved in the running of the QC Chemistry laboratory including optimisation of the working processes for the laboratory as well as the maintenance and upkeep of laboratory instrumentation. The Specialist will play a leading role in the execution of QC laboratory tasks, working closely with colleagues in other local and corporate departments. They are required to work in a GMP environment meeting all expectations associated with the support of sterile manufacturing. This role will report to the QC Manager.
Essential Duties and Responsibilities:
- Works with manufacturing, technical and other quality colleagues as part of a team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
- Prioritises safety and is diligent in the use of all appropriate safety tools, PPE and permits when sampling or when testing in the laboratory.
- Maintains a high standard of housekeeping within the Laboratory.
- Sampling and testing of raw material, in-process materials, finished and stability products.
- Works with a high level of analytical instrumentation, may be involved in the qualification of these instruments and in their routine maintenance.
- Should be capable of recognising atypical test behaviour and normally encountered equipment failure.
- Control and management of stability activities.
- Support quality aspects of materials management including supplier approval, supplier complaints and specification management.
- Actively participates and can lead laboratory investigations using structured problem solving processes.
- Develops lab procedures and supports site procedure development as required.
- Executes validation protocols for process validation and method validation. Participate in lab process validations, cleaning validations and equipment qualification.
- Reviews laboratory data and documentation as assigned.
- Daily up-keep and maintenance of Laboratory Equipment.
- Executes validation protocols for process validation and method validation. Participate in lab process validations, cleaning validations and equipment qualification.
- Is diligent in the completion and review of batch and testing documentation required to meet cGMP requirements.
- Accurate and timely recording of all GMP information is particularly important in a GMP laboratory.
- Always prepared to escalate any safety, quality or performance risk observed.
Qualifications & Experience Required:
- Degree in Chemistry or equivalent
- Experience in the use of HPLC, HIAC, Osmometer, pH etc. as well as classical wet chemistry analyses.
- Minimum of 2 - 5 years of experience in cGMP Quality Control Chemistry Laboratory environment.
- Familiarity with OOS management, problem solving and root cause analysis required.
- Experience of method validation and method transfer.
- Strong understanding of the requirements of the Regulatory Standards
* Full right to work in Ireland is required for this role.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.