Key Role Specific Requirements

• 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
• Management of laboratory activities, including tracking/purchasing of laboratory chemicals
• Inventory control of stability samples, finished product samples, and raw material samples
• Approval, manage, train, and scheduling of laboratory personnel
• Responsible for providing QC laboratory support to production
• Review and approval of quality documents
• Coordination and maintenance of stability program
• Trend analysis of product testing and stability testing
• 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
• Periodic monitoring and verification of laboratory personnel to ensure compliance to written procedures and/or regulatory requirements
• 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

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.

Core Behaviors, Skills, & Abilities:

• ADAPTABILITY/CHANGE AGILITY – Is the ability to be agile and adapt to constant change; shows good resistance to pressure and stress; is resilient and open-minded. The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness; initiating, sponsoring, and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose, and embraces change. Strives for continuous improvement.
• ENGAGEMENT, DRIVE AND EMPOWERMENT - The ability to convey confidence in employee’s ability to be successful, especially at challenging new tasks; delegating significant responsibility and authority to engage employees; allowing employees freedom to decide how they will accomplish their goals and resolve issues.
• LEADERSHIP – is the ability of an individual to influence or inspire followers or other members of the organization; to enhance others’ commitment to their work and to a high -performance culture. Provide motivational support, and the ability to develop and communicate goals in support of the business mission. Provides direction with purpose and alignment to Company vision and values.
• EMOTIONAL INTELLIGENCE – is the capacity to be aware of, control and express one’s emotions and to handle interpersonal relationships judiciously and empathetically. Uses one’s emotions productively to manage their own and others’ behavior and is aware of their emotions.
• COMPLEXITY/STRESS MANAGEMENT /TIME MANAGEMENT-The ability to keep functioning effectively when under pressure and maintain self-control in the face of hostility or provocation. Cuts through complexity to focus on core issues; ability to manage time smartly; manages resources soundly.

Other Requirements

Essential:

• 3-5 years of manager or supervisor experience
• 4-7 years of analytical chemistry experience
• Bachelor’s degree in a related science field
• Direct knowledge of Quality Control methodologies
• Working knowledge and troubleshooting of HPLC, UV/VIS, GC, and dissolution
• Some knowledge of microbiology testing and assay
• Must have and display strong leadership abilities in respect to problem solving, initiative, passion, strategic thinking, and knowledge
• Privileged to highly confidential and sensitive information requiring a high degree of confidentiality, integrity, and trust
• Experience with FDA compliance & pharmaceutical manufacturing
• Knowledge and experience with continuous improvement programs
• Experience with root cause analysis

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 eight 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 eleven manufacturing facilities across eight 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.

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