What are the responsibilities and job description for the Microbiology Manager position at Piramal Pharma Solutions?
Business: Pharma Solutions
Department: Microbiology (MQC)
Location: Lexington
Job Overview
The Microbiology Manager provides oversight of activities related to microbiological testing of bulk and finished products, packaging materials, scale-up samples, process validation samples, marketed stability samples, development and investigational samples
Reporting Structure
Directly reports to Director, Quality
Key Responsibilities
- Effectively mentor and manage the Microbiology analysts in the laboratory
- Provide and/or manages cGMP and safety training to the Micro staff
- Provides information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries
- Develop/implement procedural guidelines within the Microbiology lab in conjunction with Quality Assurance
- Conduct or manage the performance of method and equipment validation/qualification exercises
- Write necessary protocols, analyze data, and compile final reports for methods and equipment protocols
- Establish, implement, and manage Lab Programs and/or Policies, SOPs, and good record keeping practices
- Ensure that all equipment in the microbiology laboratory is functional and in a calibrated state
- Troubleshoot equipment and methods and communicate with vendors and outside contract laboratories.
- Train analysts in laboratory practices and standard microbiological procedures
- Manage and ensure that smooth function of the laboratory daily activities, including organizing the frequency of testing and prioritizing workload on a daily basis
- Analyze and trend sample results and perform statistical studies and evaluations of key performance indicators.
- Regularly monitor applicable internet and written information published by US FDA, pharmaceutical manufacturing and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into routine PPS laboratory operations
- Establish short and long-range plans for the timely and efficient execution of the microbiological testing activities within scope of the business priorities and applicable regulatory requirements (FDA, OSHA, etc.)
- Ensure Lab Sustain Permanent Inspection Readiness (PIR)
Education Requirements
- Bachelor of Science in Microbiology, Biology, Life Sciences, or related scientific discipline.
Work Experience
- 4 years of experience managing high throughput Microbiology Laboratories
- 5 years of applied Microbiology experience in a commercial pharmaceutical, GMP manufacturing environment (preferably parenteral and in a CMO/CDMO/Clinical Environment)
- Prior management/supervisory experience in a laboratory environment
Functional Or Technical Skills
- Possess excellent technical writing and oral communication skills.
- SME as it relates to Micro Lab Operations, EM, SAL and the following pharmaceutical Industry guidelines, standards, and statutes: ISPE (International Society of Professional Engineers) guidelines ,FDA and PDA Parenteral Drug Association guidelines, cGMP pharmaceutical industry standards for cleaning, sterilization, and environmental monitoring and control, US Code of Federal Regulations, Titles 210 and 211, US Pharmacopoeia methods and general information chapters related to sterility assurance.
- Knowledge and understanding of cGMPs; Knowledge of cGMP validation requirements and techniques
- Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques
- Experience managing direct reports
- Proficiency using Microsoft Office applications