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.