Commercial Attribute Scientist

Desired Skills: compliance,visual inspection,regulatory

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:

Overview: Commercial Attribute Sciences – Senior Associate (GCF Level 4-1)

This role will be responsible for supporting activities related to the Forensics and Defects group operating within the ADL 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 at ADL 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 at ADL.
• 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.

To apply, please call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***