Job Description Summary

Job Description

REPORTING TO: QC People Team Leader

PURPOSE:  

To provide Quality Control support during batch manufacture and filling process. 

MAIN RESPONSIBILITIES

Graduate role specific:

FP team project & Testing SupportRunning Team Boards & MetricsShadowing PTL and acting as designee.Ownership of TW records, attending IRB, deviation reduction plans, GMP slide preparationShadow Lead specialist and run team meetingsSupport a specialist project- transfers, method validation etc.Leading a QC Improvement Project

Roles and Responsibilities:

Carry out routine analysis on Finished Product samples ensuring compliance with cGLP/cGMP and that turnaround times are met. The testing carried out includes but is not limited to: HPLC, Osmolality, Organic Iodine, Inorganic Iodine, Thin Layer Chromatography, Free aromatic amines, pH, RI, Trom’s, EDTA, Technical tests, Extractable volume.Assisting in the maintenance of the stability programActively involved in InvestigationsLogging of samples in LIMSEntering results on LIMS, checking results are within specification and also task approval.Always ensure compliance with EHS, actively participate in EHS activities.Perform routine instrument calibration checks at appropriate times.Preparation and control of Standard Operating Procedures and always ensuring compliance with cGMP guidelines.Completion of Documentation for Batch Release process.Assisting in the provision of trendsAssist in audits.Generation/ reporting of Key performance indicators for the group.Ensure compliance with current pharmacopoeias and all regulatory/company guidelines.Interaction with other departments e.g., QA, BU, Sterility assurance etc.Keep colleagues informed of current issues and developments as appropriate.Reasonable level of overtime will be required to facilitate the business needs.Carry out additional duties as deemed necessary by your Group Leader/ Supervisor.

PRINCIPAL QUALIFICATIONS:

A third level Science Qualification

Skills REQUIRED:

Good communications skills, excellent time management skills, flexibility and agility will be required. Openness to change. Proven ability to work on own initiative and deliver expectations. 

DESIRED WORK EXPERIENCE:

Pharmaceutical experience in a GMP regulated laboratory environment.

Additional Information

Relocation Assistance Provided: No