Reporting to the Production Manager, this role is responsible for efficiently supervising production operations and ensuring the production schedule is achieved in accordance with safety regulations, cGMP, and regulatory compliance. Anticipates and takes action to resolve issues relating to materials, operations, or other factors that may result in production delays. Participates in budget planning and promotes growth within the facility by implementing continuous improvement concepts, developing employees, and leading by example. Responsible for effectively coordinating required maintenance activities to ensure minimal conflict with the production schedule.
- Ensures that established policies, rules and regulations, and Standard Operating Procedures (SOP’s) are followed. Reviews/Revises SOP’s on a two year review cycle and prepares new SOP’s on an as needed basis. Ensures SOP, Safety and cGMP training is current for staff.
- Verifies correct identification, weights, and warehousing of raw materials;
- Conduct and complete investigations; Complete deviation reports, complaint investigations, and environmental notifications.
- Ensure calibration/verification of equipment is current; maintains thorough knowledge of processes and equipment.
- Ensure the accurate and timely review and completion of production batch records.
- Evaluate KPI information to identify bottlenecks within the facility; provide and support improvement initiatives across the site (Production, Engineering, Quality).
- Responsible for batch production, employees, safety and housekeeping of the area and meeting production quality and quantity standards. Reports any process and equipment problems to Production Manager.
- Build empathy and trust by listening, understanding, coaching, training, and supporting staff members.
- Set performance goals and objectives with direct reports. Responsible for training sterile operators and packaging label operators.
- Plan, direct and coordinate staff to ensure production demand is met; Supervises daily activities of assigned production personnel and manufacturing operations.
- Performs other related projects or tasks as may be assigned by Management.
- A minimum of 3+ years supervisory experience in a quality regulated pharmaceutical manufacturing facility
- Degree in Business Management, Biology, Chemistry, or equivalent life science; or significantly direct, relevant, equivalent experience in lieu of a degree will be considered
- Must possess a general understanding of pharmaceutical manufacturing
- Candidates must be familiar with drug cGMP’s and the concept of Total Quality Control
- Candidates must be knowledgeable of warehouse operations, material, and personnel flow.
- Comprehensive knowledge of Microsoft Office Suite, and computer literate.
- Experience with aseptic processing, aseptic technique, and operations in a clean room (Grades A to D).
- Ability to communicate effectively with al levels of employees and management; excellent written and verbal communication skills are required.
- Understand DMAIC or A3 problem solving methodology
- Led and wrote investigations
- Identified and implemented CAPAs
- Strong leadership, interpersonal and team building skills are required.
- Ability to work in a collaborative manner with a wide range of staff throughout the company
- Must be able to manage competing priorities
- Must possess the desire to build and empower staff skills and opportunities
- 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 in English.
- Degree in Manufacturing Technology, Engineering, or related field
- 2-3 years of Continuous Improvement experience – Green, Black Belt certification is a plus.
- Knowledge of mechanical engineering, electrical and instrumentation systems
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