Analytical Scientist

PE Global; Dublin; On-site; EUR 65,000 - 80,000; Full time

Job summary

PE Global are recruiting a Commercial Attribute Sciences - Sr Associate to be based in our Bio client site in South Dublin on a 12 month initial contract. The role focuses on supporting the Forensics and Defects group, including identification of drug product defects and maintaining extensive defect panels used for automated and manual visual inspection of vial and syringe products.

The successful candidate will have a background in the pharmaceutical industry, strong communication skills, and a

Qualifications

• Degree in Analytical Chemistry or Biochemistry or related discipline.
• 3–6 years of pharmaceutical industry experience.
• Familiarity with cGMP and regulatory expectations.

Responsibilities

• Lead or assist forensic investigations and write investigations to cGMP standards.
• Maintain, distribute and upkeep extensive defect panels for inspection equipment.
• Provide cross-functional support for the Attribute Sciences function.
• Document analytical data timely in the electronic notebook system.
• Understand data flow in laboratory systems and data integrity.
• Participate in internal/external audits and inspections as required.
• Ensure laboratory safety and compliance with GMP and LMS training.
• Plan and implement procedures to maximise operating efficiency.

Skills

Forensics

Defect investigation

Data Integrity

cGMP

Analytical Chemistry

Education

Analytical Chemistry / Biochemistry degree

Job description

PE Global are currently recruiting for a Commercial Attribute Sciences - Sr Associate - role to be based in our Bio client site in South Dublin on a 12 month initial contract:

Job Description:

This role will be responsible for supporting activities related to the Forensics and Defects group operating within the CAS team as outlined below:

• Forensics & Defects activities involving forensic identification of Drug Product defects and maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products.

The successful candidate will have proven experience acquired in the Pharmaceutical Industry, have a right first-time mindset, be a team player, have excellent communication skills and be focussed on delivering on our customer needs.

The successful candidate will also have a strong understanding of Data Integrity principles, Quality and Compliance in the laboratory as well as good presentation/influencing skills.

Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.

Key Responsibilities:

• Leads / assists forensic investigation and identification of defects arising from drug product manufacture and write up of these investigations to cGMP standards.
• Be accountable for the maintenance, distribution and upkeep of extensive defect panels used for the set-up, training and characterisation of automated / semi-automated / manual finished drug product visual inspection equipment
• Act as support for the Attribute Sciences function on cross functional teams/programs
• Timely documentation of Analytical data in the electronic notebook system.
• Understanding of data flow in laboratory systems and data integrity.
• Participate in the peer review of analytical data.
• Compliance with Standard Operating Procedures for the Attribute Sciences Laboratory.
• Ensure the laboratory is operated in a safe and environmentally friendly manner.
• Ensure ongoing compliance with phase appropriate GMP, including compliance within the LMS training system.
• Ensure high levels of Laboratory housekeeping are maintained including inventory control of samples and consumables.
• Ensure timely completion of Laboratory Investigations, Deviations , PMAFs
• Participate in internal/external audits/inspections as required.
• Plan and implement procedures and systems to maximise operating efficiency.
• Manage and contribute to the achievements of department productivity and goals.
• Engage with the Continuous Improvement Process and MyGreenLab philosophy.

Qualifications:

• At a minimum a third level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline.
• Have 3-6 years of experience in the Pharmaceutical Industry

Knowledge and Experience:

• Excellent written and verbal communication skills
• Experience with Regulatory inspections and interaction with inspectors is preferable.
• Experience working with teams and influencing decisions.
• Skilled in the use of problem-solving tools/techniques
• Experience with developing, validating, troubleshooting, analytical methods.
• Understanding of the Change Control and Variation Management Process
• Understanding how the use of statistical tools, such as multivariate analysis can aid troubleshooting.
• Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.