Section Manager

3 days ago

Bareilly, India Panacea Biotec Full time

JOB SUMMARY:


Section Manager- Microbiology shall be responsible for organizing and managing the Quality Control Microbiology Section and assuring that Microbiology Lab operations and testing are performed in compliance with applicable regulations, company specifications, procedures, and policies and current industry practices. He is also responsible for leadership in all microbiological aspects relevant to manufacturing of product at Panacea Biotec Ltd.


RESPONSIBILITIES:


  • Monitor sampling and testing as required for environmental and personnel monitoring, samples of raw materials, in-process product, and finished product.
  • Monitor sampling and testing as required for monitoring of critical systems; Purified Water, Clean Steam, Clean Compressed Air, etc.
  • Monitor testing apparatus, solutions, media, cultures, and reagents as required.
  • Monitor quantitative and qualitative microbiological tests such as for media controls, enumeration, sterility testing, absence of index organisms, classification and speciation, antimicrobial effectiveness, etc. performed by all QC Microbiology personnel.
  • Train and qualify personnel for Aseptic Operations, Microbiological Sampling and Testing, and associated documentation. Train Microbiologists, assign tasks, monitor their performance, and review their testing and documentation.
  • Review of Laboratory Logbooks as detailed in applicable procedures. Prepare periodic reports for tracking, evaluation of trends, associated metrics, etc.
  • Monitor calibration checks and performance checks of instrumentation and devices such as pH meters, balances and refrigerators.
  • Provide support for product development projects, investigations, monitoring of utilities systems, and the stability program.
  • Track and report Quality System Metrics relevant to testing, OOS Investigations, and training in support of Quality Systems Reporting to management.
  • Provide Support for Audits and Inspections.


SPECIFIC JOB KNOWLEDGE, SKILLS AND ABILITIES


  • Must be proficient in microbiology analytical techniques and methodologies including membrane filtration methods, pour plate methods, gram stains, colony counting, and aseptic techniques.
  • Experience in antimicrobial effectiveness testing, sterility testing, method validation, Environmental monitoring program, cleanroom practices, and equipment qualification preferred.
  • Must be proficient in preparation of documents such as Protocols, SOP, specifications, Gap assessment, risk assessment
  • Must have experience to handle the QMS element i.e. deviation, change control, CAPA, incident etc.
  • Must be able to effectively communicate with large groups and work collaboratively.
  • Excellent verbal and written communication

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