ADCAN Pharma, a thriving pharmaceutical manufacturing company based in Abu Dhabi, is seeking a highly motivated and experienced QC Microbiologist to join our dynamic team. This is an excellent opportunity to contribute to a growing organization committed to quality and innovation within the pharmaceutical industry. We offer a competitive salary and benefits package in a stimulating work environment.
Responsibilities of the QC Microbiologist:
The QC Microbiologist will play a vital role in ensuring the quality and integrity of our pharmaceutical products. Key responsibilities include but are not limited to:
- Quality System Management:
- Develop, review, and revise Standard Operating Procedures (SOPs) for the microbiology laboratory, ensuring alignment with current Good Manufacturing Practices (cGMP) guidelines and the Quality Management System (QMS).
- Proactively manage and coordinate all Quality Management System (QMS) action items, including investigations for change controls, deviations, Corrective and Preventive Actions (CAPA), Out-of-Specification (OOS) results, and Out-of-Trend (OOT) results. This involves meticulous documentation, timely reporting, and effective problem-solving.
- Execute comprehensive document control activities to ensure the effective implementation and maintenance of the QMS, strictly adhering to cGMP regulations.
- Microbiological Testing and Analysis:
- Perform a wide range of microbiological laboratory analyses, ensuring accuracy, precision, and compliance with regulatory standards.
- Prepare and maintain microbial cultures, growth media, and standard solutions necessary for testing.
- Conduct environmental monitoring and sampling, including water systems (purified water, water for injection), equipment hold times, and cleaning validation procedures.
- Analyze collected data, preparing comprehensive trend analyses for water samples and environmental monitoring results to identify potential issues and implement corrective actions.
- Laboratory Maintenance and Support:
- Maintain the microbiology laboratory in accordance with cGMP requirements, ensuring a clean, organized, and compliant workspace.
- Assist in preparing for regulatory inspections by ensuring all documentation is up-to-date and compliant.
- Provide support for analytical activities, including preparation of petri plates, autoclaving, labeling, weighing, and requesting documents from the Quality Assurance (QA) department.
- Additional Responsibilities:
- Perform any other GMP-related tasks as assigned by management or the reporting manager. This may include contributing to special projects or providing support to other departments as needed.
Qualifications:
To be successful in this role, candidates must possess:
- A Bachelor of Science degree in Microbiology, Pharmacy, or a closely related scientific discipline.
- A minimum of 2-3 years of experience in a pharmaceutical microbiology laboratory environment. Experience in a GMP regulated environment is essential.
- A comprehensive understanding of Good Laboratory Practices (GLP) and relevant regulatory requirements (e.g., FDA, EMA).
- Demonstrated proficiency in performing various microbiological tests and analyses.
- Excellent organizational skills with attention to detail and accuracy.
- Strong problem-solving and analytical skills.
- Experience with SAP software is a plus.
- Exceptional communication and teamwork skills.
How to Apply:
Interested and qualified candidates are encouraged to submit their applications and resume to careers@adcanpharma.ae. Please include a cover letter highlighting your relevant experience and skills.
