Quality , Science, Pharmaceutical & Food

Scientist – HPLC

Posted 2 years ago
Contract
Remote
Tipperary
41832185

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

The ADC Laboratory Analyst is responsible for the execution and documentation appropriately of testing and analysis of Raw Materials, Intermediates, Drug Substance & Drug Product in accordance with Quality 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 & to provide training for other Laboratory Analysts and other lab personnel.

Principal Accountabilities:

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,Drug Substance, Drug products in accordance with Quality Standard 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 astandards.
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 in line with site and divisional procedures.
Complete documentation checks (e.g. PCR’s, ACRs, Deviations) as required for the Drug Substance/Drug Product test package prior to release.
To complete testing as required on samples to support process changes.
Accountable for own laboratory safety practices.
To provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision.
Provide leadership in the laboratory aspects of OOS investigations.
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. stability programme, instrument management and other systems) in a comprehensive manner and under minimum supervision.

Qualifications/ Skills Required:

Graduate of a science-based discipline – Minimum of BSc in Chemistry or related discipline
3-5 years’ experience in a similar position
HPLC/GC and Ion Chromotography experience in addition to wet chemistry techniques.
Empower experience is an advantage;

Core Competencies:

Have knowledge of GMP standards
Have knowledge Laboratory safety standards
Must have good communication skills, both written and verbal.
Strong documentation skills are required.
Must be motivated, focused and technically strong.
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 GMP expectations
To understand and internalise procedures relevant to GMP operations
To communicate clearly and concisely on technical issues
On assignment, to deliver project goals on time.
Analytical chemistry – demonstrated ability in all technical elements relevant to Ballydine ADC IPT operation
Technical lab skills (precision, etc)
Strong aptitude for handling analytical instruments
Mechanical and computer
Communication – written, oral
Team and interpersonal skills
Leadership skills