Piramal Pharma Solutions (PPS)
Designation : Senior Executive
Function : QC
Functional Area : Microbiology
Job Role Summary : Microbiology QC Samples Analysis, Environmental Monitoring, Documentation and Review
Job Profile :
- Perform microbiological environmental monitoring of manufacturing areas and the microbiology laboratory as per approved procedures.
- Conduct microbiological testing of raw materials, packaging materials, finished products, in-process samples, stability samples, and water samples in accordance with approved specifications and pharmacopeia requirements.
- Perform sterility testing of raw materials, packaging materials, and finished products while maintaining complete and accurate documentation.
- Maintain, calibrate, qualify, and monitor microbiology laboratory instruments and equipment, including incubators, as per approved schedules.
- Ensure timely sampling and microbiological analysis of purified water, potable water, and other utility water systems.
- Maintain laboratory documentation in compliance with cGMP, GLP, ALCOA+ principles, and data integrity requirements.
- Ensure timely and accurate data entry in the applicable laboratory software.
- Participate in internal, external, customer, and regulatory audits, ensuring audit readiness and compliance with regulatory requirements.
- Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and microbiological failures in coordination with the Head of Department (HOD), and implement appropriate Corrective and Preventive Actions (CAPA).
Job Requirements :
- 4-6 years experience in Microbiology department in Pharma Industry
- Exposure to cGMP requirements and compliance for regulated markets
Work / Job Experience : 4-6 Years
Type of Experience : Pharma Microbiology QC experience
Academic Qualifications :
Post Graduation in Microbiology stream - MSc, MPharm