Job Description

Key Responsibilities:

To perform quality control microbiological testing of raw materials, incoming goods, intermediates, and/or finished products under cGMP conditions for QC release or as part of stability studies To support monitoring for facility's utilities systems To support equipment qualification To perform and coordinate calibration, and maintenance of laboratory equipment To be involved in aseptic process simulations To support method transfer/verification/validation for new product introduction To perform periodic reviews for laboratory documents To lead microbiological inventory management To maintain the accuracy, completeness, and compliance of laboratory data To maintain individual's training records To support continuous improvement activities To communicate in site and global platforms To ensure cGMP is applied and adhered to in their area of work To collaborate with HSE, cGMP and always maintain a 5S approach To perform tasks required by the Manager To support shift work .

EH&S:

Understand emergency procedures and follow safe systems of work. Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times Ensure timely reporting and investigation of all accidents, near misses and breaches

Minimum Requirements/Qualifications:

Degree in Microbiology, Biology or strongly related scientific field with minimum 1-2 years of laboratory experience Experience in basic microbiological techniques e.g. bioburden testing, endotoxin testing, and environmental monitoring Basic proficiencies in Microsoft Words, Excel, PowerPoint Knowledge in FDA/EMA/HSA/Global regulatory requirements applicable to microbiology and environmental monitoring in biologics. Ability to work independently and follow critical timelines Adaptable to a changing work environment Effective interpersonal attributes at all internal and external levels. Excellent attention to detail. Good time management and project management skills * Self-motivated individual