Quality , Science, Pharmaceutical & Food

Lab Analyst – Tipperary

Posted 3 weeks ago
Contract
Tipperary
41976650

PE Global are currently recruiting for a Lab Analyst for our client site in Tipperary:

6 month initial contract – Analytical Chemistry

Job Purpose:

To execute and appropriately document testing of Raw Materials, Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols. To 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

Role Functions

(Functions include, but are not limited to, the following)

The Laboratory Analyst has responsibility for Raw Material, Intermediate, Drug Substance & Drug Product 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, Drug Substance & Drug Product 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. 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.

Experience, Knowledge & Skills

Core Competencies

Technical:

Relevant GMP standards
Lab safety standards

Business:

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

Leadership:

Analytical chemistry – demonstrated ability in all technical elements relevant to operation
Technical lab skills (precision, etc)
Strong aptitude for handling analytical instruments
Clear understanding of DI requirements
Mechanical and computer
Communication – written, oral
Team and interpersonal skills
Leadership skills

Qualifications & Education

Educational Requirements: