- Microbiological testing as per USP <60> , <61> and <62> for RMs, In-process bulk, F/G and stability samples.
- Microbiological testing of purified water and city water.
- Environmental monitoring including active air, passive air, surfaces, compressed air and non-viable particulate counts.
- Perform microbial recovery studies for method validation.
- Perform Antimicrobial effectiveness studies and intrinsic antimicrobial testing.
- Antibiotic assays using cylinder plate method and turbidimetric analysis
- Media preparation, sterilization and QC testing of culture media for sterility and growth promotion tests
- Media preparation, sterilization and QC testing of culture media for sterility and growth promotion tests
- Operation and maintenance of microbiology laboratory equipment
- Document test results as per SOP and GMP
- Recognizes OOS or out of trend results and under the direction of the Supervisor/Manager assists in the completion of lab investigations
- Interpret data, communicate results and complete written reports
- Complete all GMP documentation correctly and in a timely manner
- Complete all training assignments and maintain personal training records
- Conduct (participate or lead) routine laboratory and Non-Conformance Investigations
- Initiate and follow through with actions required to close Change Controls
- Evaluate methods and procedures and suggest improvements and changes as required
- Interpret data and complete written reports
- Routine maintenance of microbiology laboratories including daily, monthly and Quarterly cleaning and sanitization of the microbiology laboratory.
- Other duties as required
- B.Sc./M.Sc. in Microbiology
- Minimum 5 years of experience in Pharmaceutical microbiology laboratory environment preferred
- Strong Microbiology knowledge/experience preferred
- Ability to apply knowledge of microbiology, math, instrumentation and statistics to complete tasks
- Ability to work effectively in a team-based environment
- Proficiency with applicable software (LIMS, TrackWise)
- Strong organizational, analytical and multi-tasking ability
- Ability to troubleshoot and resolve issues
- Excellent written and verbal communication skills to support testing records, reports and investigations
- Thorough understanding of GMP's
Analyst, Microbiology - Brampton, Canada - SUN PHARMA
Description
Taro Pharmaceuticals Inc. is a multinational, specialty pharmaceutical company with a vision of reaching people and touching lives globally as a leading provider of valued medicines. We are dedicated to meeting the needs of our customers and the overall community through the innovation, development, manufacturing and marketing of the highest quality healthcare products.
Established in , Taro's world class production facility is located in Brampton, Ontario, with a current team of over Canadian employees. Our company's focus on the dermatology sector has made us a leading manufacturer and supplier of specialized topical products with a diverse portfolio of creams, ointments, liquids, and gels.
With support from our parent company, Sun Pharma, one of the world's largest specialty generic pharmaceutical companies, we are committed to providing a healthy, safe and rewarding environment for all of our employees.
Our reward packages have been designed to meet the needs of our diverse workforce and their families. For additional information visit: .
What we offer:
A safe and clean; GMP regulated work environment
Opportunities for career growth and development
A competitive wage/salary
Employee training and organizational development programs, internal mobility programs, and employee recognition programs
Our Brampton location is presently looking for Analyst, Microbiology
Job purpose
The main responsibility of this position is to generate accurate results while following GMP requirements. Responsible for microbiological testing in microbiology laboratory, in accordance with established compendial and in-house testing methods, while under minimum supervision.
Duties and responsibilities
Qualifications
Working conditions