Microbiology Specialist - Team Leader (Sydney Australia)
Reports To Role: Microbiology Quality Manager
Provides advanced technical assessment and planning support for the Environmental Monitoring or Quality Control Testing Microbiology Team per roster to ensure the following:
Microbiological Team conducts Quality Control testing on raw materials, water, bulk and finished product, and Microbiological Environmental and Personnel testing in a timely manner and in compliance with specifications and regulatory requirements.
Support the microbiological team with other activities as required.
Liaison between Production and Microbiology Laboratory
Provide advanced technical support to all production teams as needed (Risk Assessments, Media Schedules, Validation activities)
Ensure that microbiological identification and investigations are conducted per regulatory requirements.
Author/Review documents (i.e. SOPs, WI, LSPs etc.) with appropriate clarity and completeness.
Technical support for routine test methods, projects, method validation and Laboratory OOS investigations.
Provide support for the Microbiological Laboratory during internal and external audits.
Act with efficiency in all job activities.
Keep abreast of new test methods and regulatory requirements and facilitate implementation in the laboratory where appropriate.
Ensure procedures and methods are aligned to global procedures, relevant Pharmacopeia's, GMP (including EU, TGA guidelines) and any other relevant regulatory requirements.
Ensure compliance of self and others to internal and external regulations
Ensure all microbiological test methods performed by the micro lab personnel are validated and conform to current validation requirements
Ensure Operations Change Management (OCMs) are appropriately generated and authorised within agreed timelines
Conduct Laboratory deviation and OOS investigations, and complete report in a timely manner
Facilitate effective CAPA implementation
Provide advice on Microbiological quality related matters to cross-functional departments
Apply the first level of risk management by using analytical skills and experience to make decisions, develop solutions, or more complicated judgements, within operating guidelines
Ensure Microbiologists are GLP/GMP trained and competent and training records are complete and up to date
Strive to ensure that team members are multi-skilled in all aspects of laboratory processes
Maintain Soup Tests and Aseptic Simulations schedule and provide guidance to production and microbiology team to ensure manufacturing regulatory compliance
Developing planning, resource management, time management, coordination of team resources and reporting systems.
Key KPIs that relate to this position:
? Schedule adherence for the following;
- Microbiological sampling, sample receipt and testing, test result review
- QN initiation and completion
- OCM initiation and closure
- OOS investigation and reporting
- Special Projects, Documentation System Management
Education, Qualification, Skills and Experience
Third level Science qualification: Minimum at BSc degree level in Microbiology or equivalent in a science discipline.
High levels of experience in Good Manufacturing / Laboratory Practices.
Sound knowledge and understanding of the principles and concepts of compliance management and Good Manufacturing / Laboratory Practice.
Sound knowledge and understanding of Occupational Health and Safety
Functional mastery of written and spoken English.
People and performance management.
Minimum 4 years' experience in a Pharmaceutical / Technical environment in Quality Control.
Minimum 1 year supervisory / management role.
Please call Gavin ++ 353 (0)1 230 2400 or email@example.com/ www.rftgruop.ie