QC Raw Materials Analyst
This vacancy has now expired
12 month contract – 3 year project
The QC Raw Material Analyst role is a critically important activity to ensure efficient and effective compliant design, construction, qualification, and operation of this new strategic Drug Substance facility.
This tremendous opportunity will be responsible for verifying the raw materials analytical methods and performing supplier qualification. This person will be key in the layout of the lab testing to ensure the process is streamlined and in line with this companies lean methodologies.
Activities within the role
- 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.
- Responsible for driving a culture of Continuous Improvement by deploying MSD Six Sigma tools
- Ability to respond to changing priorities.
- Strong organisational skills
- Good verbal and written communication skills
- Excellent troubleshooting and problem-solving skills
- Good attention to detail
- Ability to think logically and be proactive.
- Ability to work as part of a team and on own initiative in a constructive manner
- Flexible and self-motivated
- 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)
If this role is of interest, please apply now.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
Republic of Ireland
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The QC Raw Material Analyst role is a critically important activity to ensure efficient and effective compliant design, construction, qualification, and operation of this new strategic Drug Substance
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