Direct message the job poster from Recruitment by Aphex
Recruitment Lead | C&Q | Validation | Quality | Life Sciences Talent Specialist 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 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.
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 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 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, App/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.
Seniority level Associate
Employment type Contract
Job function Science
Industries Pharmaceutical Manufacturing
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