Job Summary:

We are looking for a skilled Microbiologist to perform microbiological testing on raw materials, in-process samples, finished products, and environmental samples. The role involves conducting microbial limit tests, antimicrobial effectiveness testing, and analyzing data to ensure products meet regulatory and quality standards. The ideal candidate will support investigations, collaborate with cross-functional teams, and help maintain GMP compliance through accurate documentation and equipment maintenance. This position requires at least 2–3 years of experience in a pharmaceutical quality control environment.

Responsibilities

 Perform microbial limit tests and microbiological assay on raw materials, in-process samples, finished products and stability study samples.

 Execute antimicrobial effectiveness testing (AET) to validate preservative systems in multi-dose products.

 Sample and monitor air, water, surfaces, and personnel in manufacturing areas to identify potential contamination sources.

 Analyse environmental data and trends to assess risks and recommend corrective actions.

 Evaluate test results to confirm that samples meet specifications, identifying and addressing any deviations or out-of-specification (OOS) results.

 Investigate quality issues through root cause analysis and recommend corrective actions to prevent recurrence, working closely with production and Quality Assurance

 Maintain accurate and detailed records, including test data, Certificates of Analysis (CoA), adhering to Good Manufacturing Practices (GMP) and regulatory guidelines.

 Prepare and review standard operating procedures (SOPs), test reports, and validation protocols.

 Calibrate and maintain laboratory equipment to ensure consistent and reliable test outcomes.

 Ensure all activities align with industry standards and regulations, such as those set by the FDA, EMA, and ICH, as well as pharmacopoeial requirements (e.g., USP, EP).

 Participate in the qualification and validation of equipment and processes related to microbiological testing

 Partner with production, R&D, and QA teams to resolve quality concerns, improve processes, and support internal/external audits.

 Stay informed about updates to industry regulations, standards, and company policies to maintain compliance and best practices.

Qualifications:

Education: Bachelor’s degree in Microbiology, Pharmaceutical Sciences, Biological Sciences, Biochemistry, or related field. A Master’s degree is a plus.

Experience: Minimum of 2-3 years of experience in a Quality Control role within the pharmaceutical or related industry.