Senior Microbiologist – Global Pharmaceutical Firm

Global Pharmaceutical Firm

Responsible for ensuring all required testing is completed in the microbiology department including in-routine and non-routine product testing and environmental microbiological testing.

ESSENTIAL DUTIES AND RESPONSIBILITIES

•Demonstrate consistently high level of quality work
•Technical Leadership – specifically within the testing of samples to support validation studies and implementing process improvements through the development of a team
•Make detailed observations, documents results and perform data analysis
•Reviewing and approving data generated from testing and to bring this to the attention of the team manager as well as reviewing any trends and out of specification results
•Provide assistance to management in investigating out of specs and trend results for microbiological data
•Create / Revise SOPs, Laboratory records, logs and other related documents
•Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols, processes and equipment
•Identify and develop corrective actions for out of compliance issues
•Perform microbiological validations as needed for products and processes
•Assist in reviewing the data and support timely product release
•Well versed with knowledge and understanding of current standards and methods pertaining to microbiology, sterility assurance, bioburdens, environmental monitoring, water testing, validations and other testing related to microbiology in drug and device industry
•Ensuring appropriate standards of cGMP are maintained as well as standards of Health, Safety and Environment are adhered to in the team
•Ensuring that the laboratory and equipment is up to date in accordance with current legislations and procedures as well as to the required GMP standards
•Good knowledge of USP and EP guidelines
•To coordinate and ensure that all team objectives are achieved as well as effectively managing a team, providing direction and coordination of all activities as well as ensuring compliance with regulatory requirements, GLP and company SOPs
•Mentoring and training of junior microbiologists.
•Assist in routine laboratory testing when necessary

JOB REQUIREMENTS

Education

•Be Degree qualified or equivalent in a scientific discipline or a Microbiologist with minimum 3 years experience.

•Be Extremely knowledgeable with regards to GMP and have a GMP background within the pharmaceutical industry
•Be Experienced with Quality Control/Microbiological testing techniques and industry best practice
•Have proven leadership skills in supervision of teams as well as good time management and communication skills
•Be Knowledgeable with regards to continuous improvement techniques and root cause analysis techniques
•Have Experience in test and equipment validation
•Knowledge of EP, USP, FDA requirements
•The application of six sigma and lean manufacturing principles and statistical process control would be an advantage