QA & Microbiology Officer

Officer - QA & Microbiology

Company: Flexicare Lanka (Pvt) Ltd

Flexicare is a leading UK manufacturer of medical devices. Backed by over 35 years of experience in design and development, supported by a modern manufacturing facility, Flexicare has built a world class reputation for the supply of consumable medical devices.

Eligibility Criteria :

• Bachelor's Degree in Microbiology, Biotechnology, Biomedical Science, or a related field.
• Minimum 1 year of experience in a medical, pharmaceutical, or healthcare manufacturing environment.
• Basic knowledge GMP and Quality Management Systems (QMS).
• Strong analytical, problem-solving, and communication skills.
• Exposure to culture media preparation, environmental monitoring, cleanroom microbiology, sterility testing, or laboratory equipment will be an added advantage.

Duties & Responsibilities :

• Manage microbiology laboratory operations, including culture media preparation, sterilization, and growth promotion.
• Perform environmental monitoring of cleanrooms, including air, surface, personnel, and water quality testing.
• Conduct microbiological testing for bioburden, product sterility, and hygiene compliance.
• Monitor and maintain laboratory equipment, including incubators, autoclaves, and biosafety cabinets.
• Ensure microbiology compliance through GLP documentation, equipment calibration, method validation, and data integrity.
• Investigate contamination, perform trend analysis, implement CAPA, and maintain laboratory biosafety and sanitation programs.
• Supervise Quality Assurance activities in compliance with ISO 13485:2016, GMP, and the QMS.
• Review and approve batch records, quality documents, laboratory reports, and product release records.
• Lead investigations of nonconformities, deviations, and customer complaints, ensuring effective CAPA implementation.
• Conduct internal and external audits, oversee validation and risk management activities, supervise QA personnel, and drive continuous quality improvement.

If you feel you are the perfect fit for the above position, please send us your details curriculum vitae along with a recently taken passport size photograph and referees within 7 days of the advertisement.

Kindly state your expected salary & the position applied in the subject line and email your application to info@flexicare.lk

Location: No.382/X, Kumbuka Road, Raigama, Bandaragama.