Complete work planning, allocation and execution of microbiology section.
Documentation review and monitoring of microbiological overall activity.
Planning for execution of the Method development and analytical method validation skill, qualification activity.
Lead the team with Manpower handling skill as manager (upto 25 staff) to execute the work in effective manner on time.
Keep regular Compliance to meet the regulatory and customer specific requirements.
Rational designing and sampling justifications for any microbiological sampling points like Environment monitoring, water testing, cleaning validation, bioburden testing.
Document Preparation for validation, qualification, SOP and specification as per pharmacopieal [USP/Ph. Eur./BP/IP] and customer specific requirement. Complete and updated on compendia and regulatory guides like USFDA, WHO, ICH, Schedule M or any Regulatory requirement. Preparation Matrix for calibration of all instrument life cycle.
Timely produce the required document and support to increase the yield of production in benefit of organization.
Decision maker and problem solving attitude with smooth functionality at work with each staff in good faith.
Preaudit Management of microbiology laboratory for USFDA, UKMHRA, party audit. Fulfilling requirement of compliance and regulatory expectation and post auditing compliance with implement of CAPA document, protocol and reports.
Keep microbiology control in quality system document like trending (Sterility, BET, EM, water, MLT, bioburden etc.) OOS, OOT, CAPA, change control procedures, deviation or any incident, other study protocol activity or any project related work.
Manage 5S system elements in critical processes. Brain storming sessions and timely evaluation for talent development.
Initiate Lean culture and strengthen the manpower for the same.
Train and empower trainee for aseptic practices, media fill activity, microbiology practices etc.
Prepare personnel by guidance of audit preparations and train personnel conducting effective training as per cGMP.
Maintain, implement documents as well laboratory as per cGMP and cGLPs.