- Our client is looking for a Laboratory Analyst to join their busy pharmaceutical facility in Co. Tipperary.
- The Laboratory Analyst will execute and appropriately document testing of Raw Materials, Intermediates and Drug Substance in accordance with Analytical Standards and/or other approved protocols.
- The successful candidate will provide analytical support to product quality investigations including the use of sophisticated analytical techniques.
- To undertake significant assignments and to work on own initiative and with minimum supervision e.g. technology transfer for new product demonstrations; new methods development; management of an on-going programme such as the Intermediate Stability programme; and to provide training for other chemists and other lab staff.
Core Duties and Responsibilities:
- The Laboratory Analyst has responsibility for Raw Material, Intermediate and Drug Substance testing to meet compliance requirements and customer targets. The Analyst may also take a leadership role in change or improvement projects in ADC or at a site level.
- The Laboratory Analyst is responsible for ensuring all testing activities comply with cGMP. The Laboratory Analyst assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as HR policies are also responsibilities of the role.
- To test Raw Materials, Intermediates and Drug Substance products in accordance with Analytical Standards and/or other approved protocols.
- To comply with all GMP and analytical procedures relevant to area of work.
- To adhere and comply with department High Performance Analytical Behaviours
- To document all testing activities and to input results into computerised lab systems in accordance with department and MMD standards.
- To provide analytical support to product quality investigations and new product demonstrations under the supervision of the Laboratory Leader or designate.
- Complete the investigation of laboratory OOSs (Z1 Quality Notifications), in line with site and divisional procedures, and Provide leadership in the laboratory aspects of OOS investigations.
- Complete documentation checks (e.g. GCM’s, Quality Notifications, Data Integrity) as required for test packages prior to release.
- To complete testing as required on non-routine samples to support process changes, Request for Service, Quality Notifications
- Accountable for own laboratory safety practices. Follow the principles of Safe by Choice
- To provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision.
- To identify and aid resolution of analytical issues within the IPT laboratory.
- To be a resource for analytical testing for the site as required.
- Execute specific assignments (e.g. Annual Product reviews, CPV reviews, DI Initiatives, Lab X Champion, Empower/LIMS Superuser and other systems) in a comprehensive manner and under minimum supervision.
- Complete training with new laboratory Analysts and Laboratory Apprentices.
- On assignment, and depending on experience, participates in or leads departmental initiatives on improved compliance and quality systems.
- Operates as part of self-directed team in allocating testing and assigning priorities.
Minimum Qualifications and Experience:
- Minimum of BSc in Chemistry or related discipline.
- To have demonstrated knowledge of MMD and site quality policies, procedures and guidelines which relate to finished product testing and release.
- Relevant GMP standards & Lab safety standards
- To perform analytical testing with a high degree of precision and accuracy
- To perform instrument maintenance and troubleshooting
- To maintain accurate records in compliance with ALCOA principles and GMP expectations
- To understand and internalise procedures relevant to GMP operations
- To communicate clearly and concisely on technical issues
- On assignment, to manage specific department projects
- To provide training programmes to laboratory staff as assigned
- To liaise effectively with external groups such as MRL, RAS, DI COE, etc.
- To act as auditee (in internal and external audits) for assigned areas of responsibility
- Analytical chemistry – demonstrated ability in all technical elements relevant to site ADC IPT operation
- Technical lab skills (precision, etc)
- Strong aptitude for handling analytical instruments
- Clear understanding of DI requirements
- Mechanical and computer
- Excellent communication skills (written and oral)
- Team and interpersonal skills, as well as Leadership skills
To Apply: Quote – PE22105
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.