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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
QC Microbiology Analyst
Job Description
To execute defined and trained Quality Control department tests for the release of raw materials, in process products, bulk drug substance, final products and stability products according to defined procedures and protocols and according with best cGMP work practices, Quality standards and metrics
Job Summary
The QC Microbiology Analyst will be responsible for performing a variety of microbiological tests on raw materials, in-process samples, finished products, and environmental samples to ensure compliance with cGMP regulations and internal quality standards at Piramal Healthcare UK Limited.
Job Responsibilities
- Execute routine and non-routine microbiological testing, including but not limited to bioburden, sterility, endotoxin, microbial identification, and environmental monitoring (air, surface, water).
- Perform media preparation, sterilization, and growth promotion testing.
- Operate, maintain, and calibrate laboratory equipment such as incubators, autoclaves, microscopes, and spectrophotometers.
- Document all testing procedures, results, and observations accurately and in a timely manner, adhering to good documentation practices.
- Interpret test results, identify out-of-specification (OOS) results, and participate in OOS investigations.
- Participate in environmental monitoring programs, including scheduling, sampling, and data trending.
- Assist in the development and validation of new microbiological test methods.
- Contribute to the investigation of deviations and implement corrective and preventive actions (CAPAs).
- Maintain a clean and organized laboratory workspace, ensuring compliance with safety regulations.
- Support internal and external audits as required.
- Adhere to all company policies, procedures, and cGMP guidelines.
Job Qualifications
- Bachelor's degree in Microbiology, Biology, or a related scientific field.
- Minimum of 1-3 years of experience in a QC Microbiology laboratory within the pharmaceutical or biotechnology industry.
- Hands-on experience with common microbiological techniques, including aseptic technique, microbial enumeration, identification, and sterility testing.
- Familiarity with cGMP, pharmacopoeial requirements (e.g., USP, EP), and other relevant regulatory guidelines.
- Proficient in using standard laboratory equipment.
- Strong attention to detail and excellent documentation skills.
- Ability to work independently and as part of a team in a fast-paced environment.
- Good problem-solving and analytical skills.
- Effective written and verbal communication skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
