QC Analyst - Ireland
Want to know company name or location? Company managed [?]
- Our company is a leading healthcare business in Britain and Ireland with sales in excess of £350 million, over 1,000 employees and an ambition to be one of the leading players in the supply of products and services to the healthcare sector in Europe.
- Our company is focused on driving organic growth in its existing businesses and identifying new growth opportunities that strengthen and expand its product range, broaden its geographical reach and improve its business.
- Our company operates across three key divisions.
- Our laboratories are one of the leading manufacturers of oral beta-lactam antibiotics in Western Europe.
Principal Duties and Responsibilities:
- Plan own schedule to ensure testing of raw materials, packaging materials, semi-finished and finished product is carried out in a timely manner and product/materials are released as per planned schedule.
- Maintenance of quality control documentation as per cGMP.
- Review of laboratory analytical test methods, SOP’s etc, to ensure compliance to cGMP regulations.
- Documentation of 2nd check of laboratory results.
- Carry out duties as per cGMP regulations.
- Maintain regular consistent and professional attendance, punctuality, and personal appearance and adhere to relevant GMP and Health & Safety procedures.
- Maintain good housekeeping practices as per cGMP.
- Disposing of laboratory waste as per relevant cGMP and Health & Safety regulations.
- Carry out routine analysis of incoming raw materials and packaging materials and releasing them in a timely manner for manufacturing use.
- Carry out routine analysis of semi-finished and finished product as per approved test methods (primarily HPLC work) and ensuring they are completed in a timely manner.
- To carry out calibration of test equipment as required.
- Preparation of packaging specifications.
- Preparation of secondary standards for routine analysis.
- Preparation of reagents for routine analysis.
- Disposal of organic and inorganic waste as per Health & Safety guidelines.
- Assist in training of new analysts as requested by QC Manager.
- Liaise with Production, Materials and Supervisor to ensure smooth production throughput.
- Liaise with Validation and Production in carrying out analytical testing as required.
- Liaise with Stability Department in improving efficiency of testing.
- Ensure that budgets are adhered to and that all spending is geared to business benefit.
Qualifications & experience:
- Third Level qualification in a scientific discipline
- The role demands a well-organised approach, underpinned by the ability to communicate effectively with people at all levels, both verbally and in writing.
- Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.
- Full-time, permanent role