PurposeThis job specification outlines the general responsibilities associated with the role of Senior Associate within the Commercial Attribute Science (CAS) Dept. of Process Development. This role will be responsible for supporting activities related to the Forensics and Defects Group, 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.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/programsTimely 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 LaboratoryEnsure 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, PMAFsParticipate 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.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 IndustryExcellent written and verbal communication skillsExperience with Regulatory inspections and interaction with inspectors is preferable.Experience working with teams and influencing decisions.Skilled in the use of problem-solving tools/techniquesExperience with developing, validating, troubleshooting, analytical methods.Understanding of the Change Control and Variation Management ProcessThis is a shift role, shifts are as follows:Shift Patterns: Two cycle shifts:Week 1: 07:00 to 15:00 Mon - Thurs, 07:00 to 14:00 FridaysWeek 2: 14:30 to 22:30 Mon - Thurs, 13:00 to 20:00 Fridays