Perform cleanroom, BSC & Isolator batch related monitoring
Utility sampling of water systems and Compressed Air/Gas.
Carrying out In-Process testing of critical lot related samples to support Manufacturing activities (HPLC and UV Spectrophotometry).
Issuance, receipt, and testing of biological indicators.
Reading and reporting of environmental monitoring, BIs, and aseptic qualification sample results.
Reconciliation and inspection of media fill units, and participation in media fills.
Carrying out identifications of Microorganisms isolated post testing activities.
Completing all laboratory documentation in a timely and accurate manner.
Compliance with Standard Operating Procedures and Registered Specifications.
Assisting in authoring and reviewing documentation.
Providing support to other departments to ensure qualification and production schedules are adhered to.
Reviewing paperwork, and reconciliation of analysis performed in the laboratory.
Ensuring that any alert/action limit excursions are investigated according to site procedures.
Receipt and processing of drug substance and drug product samples.
Adherence to and improvement upon lean lab and 6S practices.
Ensuring a high standard of housekeeping and safety is maintained in the laboratory.
Performing any other activities as indicated by the Microbiology Manager.
Qualifications
The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline.
At least 2 years' experience in a pharmaceutical / healthcare laboratory or related technical function.
Applicants should have relevant experience working in a cleanroom environment using aseptic techniques, and experience working with isolators is advantageous.
Experience in HPLC and UV Spectrophotometry is desirable but not essential.
Experience using MODA, Empower, CIMS, LIMS, LES and Veeva Vault is desirable but not essential.
The successful candidate must demonstrate excellent written and verbal communication skills.
The ability to work in a team based collaborative environment is essential.
