- Supervise a department of analysts, technicians, and microbiologist to assure materials are tested on-time and according to cGMP and company procedures.
- Conducts or assists in periodic audits of contract testing laboratories.
- Interacts with Regulatory Authorities during plant inspections regarding QC laboratory issues.
- Scheduling, testing, and approval of excipients, API’s, and finished products
- QC Supervision of laboratory activities, including tracking/purchasing of laboratory chemicals.
- Inventory control of stability samples, finished product samples, and raw material samples.
- Review and approval of quality documents.
- Coordination and maintenance of stability program.
- Coordinating of out-of-specification investigations and deviation investigations.
- Development of Standard Operating Procedures and Test Methods pertinent to Quality Control (QC) activities and functions, as well as other procedures if deemed necessary.
- Provide training on procedures and methods, as needed.
- Review of batch records for compliance of manufacturing processes/steps, ensuring that all applicable documents, records, and forms are completed and attached.
- Responsible for analytical method transfers for contract manufacturing.
- Responsible for USP method verification protocols and reports.
Essential Skill Requirements:
- 4-7 years of analytical chemistry experience
- Bachelors Degree in a related science field
- Direct knowledge of QC methodologies
- Must possess excellent communication skills for liaising and communicating with vendors, customers, and internal departments
- Strong problem identification and problem resolution skills
- Must be able to quickly assess the compliance risk of events and make decisions that are scientifically sound, compliant to the regulations and defensible
- Working knowledge and troubleshooting of HPLC, UV/VIS, GC, and dissolution with some knowledge of microbiology testing and assay being a plus
- Highly motivated and self-directed capable of multi-tasking, and able to work with minimal supervision
- Extremely detail-oriented and analytical thinker
- A well-defined sense of diplomacy, including solid negotiation, conflict resolution, and people management skills
- Must have and display strong leadership abilities in respect to problem solving, initiative, passion, strategic thinking, and knowledge
- Preferably experience in an FDA, Canadian Health, and or EU regulated Pharmaceutical manufacturing environment
- Supervisory experience
- Knowledge and experience with continuous improvement programs
- Experience with root cause analysis
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 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