Key Role Specific Requirements:
- Responsible for providing support to Production through the receipt, analysis, and review of raw materials, finished products, and stability samples while following cGMPs.
- Perform out-of-specification investigations and all required documentation per cGMPs and company procedures.
- Support and contribute to Continuous Improvement Initiatives within the company.
- Operate, troubleshoot, and maintain analytical instrumentation used in the laboratory, such as HPLC, GC, FTIR, dissolution apparatus, and TOC analyzer.
- Review and revise procedures and analytical methods as required to ensure compliance.
- Perform method verification, validation, or method transfers for HPLC, GC, and other analytical procedures.
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.
- 1-5 years of analytical chemistry experience.
- Practical experience with GMPs within a regulated environment.
- Bachelor’s degree in related science field.
- Working knowledge and troubleshooting of HPLC and GC.
- Excellent English verbal and written skills for liaising and communicating with internal departments.
- Strong problem identification and problem resolution skills.
- High level of proficiency with Microsoft Office.
- Highly motivated and self-directed, capable of multi-tasking, and able to work with minimal supervision.
- Extremely detail-oriented and analytical thinking with a strong work ethic and a positive team attitude.
- Experience in an FDA, Canadian Health, and or EU regulated Pharmaceutical manufacturing.
- Knowledge of USP methodologies.
- Knowledge and experience with Continuous Improvement program.
- Knowledge and troubleshooting of FTIR, UV/VIS, and dissolution apparatus.
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 optimize the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation program sees six state-of-the art R&D centers 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 commercialization 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