This is a 12-month initial contract.
This is an on-site Laboratory based role with responsibility for Analytical Support activities involving:
* Analytical Method Troubleshooting,
* Analytical Method Lifecycle (Development, Qualification, Validation, Remediation)
* Analytical support for Process Development and Qualification activities at the site and wider network.
The successful candidate will have proven analytical experience acquired in the Pharmaceutical Industry, have a right first-time mindset, be a team player, have excellent communication skills and be focused 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:
* Analytical method troubleshooting, qualification, validation, bridging, transfer.
* Analytical support for Process Development and Process Qualification activities.
* 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 maximize 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 relevant analytical experience in the Pharmaceutical Industry.
Knowledge and Experience:
* Subject Matter Expert for General and Compendial methods used in the analysis of Drug Product such as Sub Visible Particle Analysis, KF Moisture, pH, Osmolality, Density, Appearance/Colour/Clarity, CCI, Breakloose and Extrusion, RAMAN, FTIR, NIR, UV/VIS Spectrophotometry, SEM.
* Experience with Chromatographic methods such as HPLC, UPLC, with UV, RID, Mass Spec detection would also be favourable but not essential.
* Excellent written and verbal communication skills.
* Science-based decision maker.
* 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 Process Validation activities (Engineering, PPQ, Comparability/Characterisation studies).
* 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.
Skills:
HPLC, Analytical Sciences, UPLC, Process Development
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