Senior Microbiologist x 2
|Title||:||Senior Microbiologist x 2|
|Sector||:||Engineering & Technical
Scientific & Laboratory
|Tel||:||021 201 9097|
Role of this position
- Responsible for QC microbiological aspects of cGMP compliance and testing.
- Perform microbiological validations as needed for finished product and in process controls and buffers.
- Assist in the identification of microbiological root cause analysis and provide technical advice as needed.
- Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.
- Participate in cleaning and process validation activities involving microbiology as needed.
- Participate in the investigation of microbiological product OOS results and DNF as needed.
- Contribute to the preparation of technical proposals, amendments, reports and memoranda.
- Contribute toward creating and revising microbiological SOPs.
- Assist in the review of EM and product release data.
- Microbiology representation and participation in cross functional site meetings.
- BS/BA in a scientific/technical discipline preferably Microbiology.
- 5+ years of relevant experience, preferably in a QC Microbiology Laboratory preferably within the pharmaceutical or biotechnology industries.
- Experience with electronic systems such as LIMS, Qumas, eDoc, Trackwise etc., is an advantage.
- Excellent communication skills, both verbal & written.
- Adaptable and flexible, willing to travel when needed.
- Collaboration and team work. Maintains the highest standards of ethical behaviour.
- Results and performance driven.
- Strong analytical ability and associated problem solving.
- Good time management and attention to detail.
- Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint.
Preferred Laboratory Experience
- Microbial Identification
- Utility Sampling
- Environmental monitoring
- Cleaning and validation studies
- Familiar with USP, JP and EP methodology
Please call JP O'Connor today for further information on 021 201 9097 or email: firstname.lastname@example.org