The full analytical scope will incorporate micro, chemistry, bioassay, raw materials, stability and in-process). Innovation and advanced analytical methods (rapid ID technics, paperless lab, etc) will allow the candidate challenge current thinking in designing for the future. The candidate will have responsibilities in analytical transfer and qualification of methods.
* The motivation to be an inspiring member of a high performing team.
* The desire to continuously learn, improve and develop.
* Perform supportive activities for general lab readiness, laboratory equipment qualification and method transfers.
* Perform and carry out a variety of routine analytical techniques including but not limited to HPLC, HIC, CE, IEX, HP-SEC, UV, pH, Colour, Osmolality, Degree of Coloration and Appearance in compliance with GMP requirements.
* Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
* Support the laboratory testing schedule to achieve an efficient QC system.
* Receive and manage samples that come into the lab for stability, in-process and release testing.
* Solution preparation, cleaning, routine equipment maintenance and system set-up.
* Writing and update of SOPs.
* Maintain good housekeeping and hygiene within the laboratory.
* Calibrate and maintain all designated laboratory instruments.
* Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
* Ensure training is current for all job functions performed.
* Assist in training new QC Analysts on routine procedures and practices.
* Order, stock and receive laboratory supplies.
* Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
* Ensure that cGMP standards are maintained at all times.
* Delivery of area performance to meet or exceed performance or quality goals.
* Promote and participate the implementation and maintenance of the relevant safety programmes.
* Participate and Comply with the Quality Management System requirements.
* Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools.
* Possibility of shift work.
* This position will be on days with the possibility of shift work when required.
* Degree or 3rd level qualification (Science, Quality).
* 1-3 years industry experience with significant knowledge and experience in working in a Raw material lab unit and working with contract labs
* Experienced in testing as per the pharmacopeia
* Working knowledge of QC Systems (Empower, elogs, Electronic Lab Notebook, LIMS)
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The Life Science Specialists