Pharmaceutical & Biotechnology

Analytical Chemist

Posted 2 months ago
Contract
Clonmel, County Tipperary, Ireland
41997421

PE Global is currently recruiting for a Analytical Chemist for a leading multi-national Pharma client based in Tipperary.

This is a 12 month contract position.

Role:

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 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

Responsibilities:

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.

Qualifications:

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 the ADC
IPT operation