- Receive and log into the laboratory all samples required for analytical support.
- Perform all quality control analytical methods as required to support Production.
- Assist in the transfer of USP methods for all new products that are developed in-house and/or site transferred into the facility.
- Perform review of notebooks and raw data for samples analyzed in the laboratory.
- Perform out-of-specification investigations and all required documentation per cGMPs and company procedures.
- Support Continuous Improvement program throughout the company.
- Operate, troubleshoot, and maintain analytical equipment used in the laboratory, such as HPLC, GC, FTIR, dissolution apparatus, and TOC analyzer.
- Interface with FDA compliance officers during facility inspections.
- Review and revise procedures as required to ensure compliance.
- Accurately document all data in compliance with GMP.
- Perform QA lines check as needed during filling and labelling to support Production.
- Perform method verification and validation for HPLC, GC, and other tests.
- Other tasks as assigned.
SPECIFIC SKILL REQUIREMENTS:
- 1-5 years of analytical chemistry experience.
- Practical experience with GMPs within a regulated environment.
- Bachelors Degree in related science field.
- Working knowledge and troubleshooting of HPLC and GC.
- Must possess excellent communication skills for liaising and communicating with internal departments.
- Strong problem identification and problem resolution skills.
- High level of proficiency with Microsoft Office.
- Good written skills.
- Highly motivated and self-directed capable of multi-tasking, and able to work with minimal supervision.
- Extremely detail-oriented and analytical thinker.
- Strong work ethic and positive team attitude.
- Speak and write English.
- Preferably experience in an FDA, Canadian Health, and or EU regulated Pharmaceutical. manufacturing environment.
- Knowledge of USP methodologies.
- Knowledge and experience with continuous improvement programs.
- Knowledge and troubleshooting of FTIR, UV/VIS, and dissolution apparatus.
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