QC Specialist with Laboratory equipment qualification experience.
Cpl are working with our client partner to source an accomplished QC or Laboratory professional with a wealth of experience in Laboratory Equipment Qualification and install experience.
The role is open to due a major capex investment into a Laboratory upgrade for the OSD manufacturing site in Athlone Co. Westmeath.
Initially this will be a 12-month Fixed terms contract directly with the company as they contain on their upgrade and growth phase. As a very progressive employer they will also consider the successful candidate for any full-time opportunities that arise in the business over the 12-month period.
The priority skill-set and relevant experience required here is “proven working knowledge of Laboratory Equipment install and validation and ideally you will have worked on some similarly related projects in your career to date”
Offering a highly competitive salary and benefits package, the role is live with full budget approval and our client partner are looking to review CV’s and set up interviews ASAP.
If you are interested then please review the job spec in full below and send your CV to me at [email protected] and I will reply to you within 48 hours of receipt of your CV and the client will provide feedback on CV’s and set up interviews etc… with 3-4 working days of receiving the CV.
Fixed-term QC Specialist grade III
Applications are invited for a temporary role (12 months) of Quality Control Specialist grade III within the Quality Control Department. The role will be based within the QC laboratory support group covering areas for laboratory equipment/software qualification, equipment decommissioning, periodic review of laboratory systems, data integrity assessments.
Reporting to the QC Support Manager the successful candidate will be responsible for the following:
- Prepare and manage project plans for equipment qualification/decommissioning
- Coordination and manage laboratory projects across multiple departments (QC, IT, QA, Validation)
- Writing/reviewing/execution of equipment validation documentation (change control, IQOQPQ, user requirements specifications, summary reports)
- Technical writing of SOP’s for laboratory equipment
- Utilisation of paperless validation system
- Preparation and Execution of data integrity assessments for laboratory systems.
- Performing periodic review of laboratory systems
- Continuous assessment of USP, EP and GAMP regarding laboratory equipment qualification and data management
- Accurate and timely recording of all information pertinent to the task being performed
- To maintain a high standard of GMP / GLP
- To maintain/adhere a high standard of housekeeping, Dress Code and Safety within the Laboratory and associated work areas
- Ensure full compliance with all training elements for the role
- BSc in a science/engineering/IT related discipline with minimum 2 years’ experience in a GMP pharmaceutical regulated work environment.
- Experience in the qualification of laboratory equipment
- Proven track record for meeting project timelines
- Understanding of USP, EP and GAMP requirements and guidelines for equipment qualification
- Understanding of 21 CFR Part 11 and Annex 11 requirements
- Experience in writing and updating SOP’s
- Be able to work on own initiative with minimal supervision
- Excellent attention to detail and accuracy