Key Role Specific Requirements:
- The position requires the individual to gown appropriately to the respective production rooms.
- Perform testing of water systems, Raw Materials, In-process, Finished Product and Stability Samples.
- Sampling for Environmental monitoring
- Evaluation of Environmental Monitoring Testing media plates
- Identification of isolates from various samples
- Preparation and Testing of Media including growth promotion.
- Document work in master production records, logbooks, data sheets, as applicable.
- maintain the Stability program for the site
- Ensure stability samples are logged and pulled as per their protocol
- Prepare and revise standard operating procedures.
- Perform out-of-specification investigations, environmental excursion investigations and deviations per company procedures.
- Support continuous improvement program throughout the company.
- Ensure all work is carried out in compliance with Good Manufacturing Practices (cGMP) and company Safety policies.
- Develop and validate testing methods used in routine analysis of incoming raw materials and finished products (i.e. LAL, Endotoxin, Bioburden)
- Provide technical support in the area of microbiology to the Manufacturing and Validation departments.
- Assist in writing validation protocols, project reports, updating laboratory documentation, SOPs, and test methods.
- Interface with regulatory and customer auditors during facility inspections.
- Trend Analysis, Other special projects (i.e. Disinfectant Efficacy study)
- Train personnel on microbiology related topics.
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.
Competencies Required for the Role:
- ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this
- CRITICAL THINKING – is the ability to be thoughtful and draw pertinent conclusions after a discussion or meeting; can eventually support the final outcomes and decisions
- EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts whilst adapting to one’s audience. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.
- FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
- THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
Other Requirements:
Essential:
- Minimum Bachelor’s degree in the Sciences
- Good laboratory technique, such as pipetting and aseptic techniques
- Good computer skills
- Excellent organizational skills
- Self-initiating/Self-directed
- Strong collaboration skills with other departments
- Must be able to manage competing priorities
- BSc in Microbiology related field.
Desirable:
- Experience in a pharmaceutical microbiology laboratory
- Familiar with cGMPs
ABOUT BIMEDA:
| 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. |