An exciting opportunity for an experienced Scientist working within Forensics & Defects in the pharmaceutical industry to join a leading biopharmaceutical company in south Dublin.
This role is fully on site to begin with and will evolve to allow one day work from home.
2 Cycle Shift pattern:
Week 1: 07:00 to 15:00 Mon – Thurs, 07:00 to 14:00 Fridays
Week 2: 14:30 to 22:30 Mon – Thurs, 13:00 to 20:00 Fridays
Shift premium: 20%
12 month contract with potential for extension.
Skills required
:
Someone with working forensic experience in microscopy, scanning electron microscopy or FTIR
Forensic / defect background is something we'd really like to have for the position.
Technical writing for reporting.
Scientific background
Analytical mindset
Someone who has exposure to project planning / compliance / track wise would be beneficial.
Responsibilities within the 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.
Responsibilities will include:
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 My Green Labs philosophy.
Experience & Qualifications:
Hold a minimum of a third level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline.
Have 3-6 years of experience in the Pharmaceutical Industry
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.