Commercial Attribute Science Snr Associate
Our client is seeking someone to join the Commercial Attribute Science department on an initial 12 month contract with potential extension. This is a hybrid role, with occasional requirement of being onsite depending on workload.
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
* 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
* Hold, 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
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O'Connell on +353 86 1263871 or send your CV to doconnell@berkley-group.com.
Employment type: Full-time
Seniority level: Mid-Senior level
Job function: Science
Industries: Pharmaceutical Manufacturing
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