- Ensures that all work is carried out in compliance with company safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
- Monitors and performs calibration of equipment, troubleshooting issues and ensuring equipment is in good working order including arranging repairs when needed with outside vendors.
- Prepares samples for analysis according to company methods and SOPs when needed.
- Performs analytical tests utilizing HPLC, GC, UV, IR, FTIR, KF and other instruments.
- Reviews laboratory documentation in notebooks, attachments, chromatography software and specification sheets for accuracy, completeness and compliance with established SOPs, specifications and methods.
- Conducts the investigation of deviations, out of specification (OOS), and non-conformances. Writes reports as required.
- Acts as a subject matter expert for the QC Laboratory and assists production/QA in routine analysis and investigations.
- Updates or writes new SOP’s as required, including new laboratory instruments utilizing the change control process.
- Prepares protocols and performs method transfer, verification, and/or validation as required.
- When required for investigations, conducts complex analytical (physical & chemical) testing of raw materials, in-process samples, finished products, gases, water and stability program samples. (i.e. pH, Conductivity, TOC, Viscosity, Potency tests).
- Provide training on procedures and methods, as needed
- Other duties as assigned
- Bachelor's degree in Chemistry or Biochemistry required. Master's or PhD a plus.
- 5-7+ years in a Pharmaceutical Analytical testing lab & supporting stability programs required.
- Analytical Wet Chemistry Lab experience using the following methods/equipment: titration, PH, Potency, Conductivity, Viscosity, TOC, UV, IR, GC, HPLC assays
- High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize.
- Ability to take initiative and work independently or in a team environment when needed.
- Good command of the English language. Must be able to read, understand, follow and comply with technical and written documents and processing instructions as well as clearly and accurately document all required information.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimise the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation programme sees six state-of-the art R&D centres across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialisation of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
More Info at www.bimedacareers.com