1. Established environment monitor management systems in compliance with regulations (EU, cGMP, USP, ISO and CFR).
2. Introduce new technology and concept of sterility and contamination control to site in process design, qualification and commissioning of new manufacturing areas, sterile filling, aseptic processing validation, contamination risk management, quality and compliance, sterilization and sterility testing, environmental monitoring, water system design and monitoring, contamination control strategic planning.
3. Provided guidance for commissioning and qualification of a new injectable production suite and ensure collaboration and commitment among multiple groups (QA, Facilities, Manufacturing, Validation, Engineering, Process Development, Bio-Safety, and Project Management) and ensure the successful new launch.
4. Developing microbial assessment SOP and template/tools to support routine operation, eg. EM and utility monitoring and batch release testing. Determine remediation plan to keep continuous improvement.
5. Actively involved in system design decision making and team meetings – insures systems are simple, sustainable, robust, and compliant
6. Trouble shooting on issues of process, labs and utility relating to quality, compliance, contamination control.
7. Provide expertise and recommend policies, procedures, and activities ensuring that robust monitoring and contamination control programs are in place including gowning, cleaning and disinfection, environmental and critical utility monitoring, environmental controls and product protections are in place throughout the facility.
8. Accomplish in recommending policies, procedures, and activities ensuring industry best practice in cleaning and disinfection, gowning, and environmental controls are in place throughout the facility
9. Assist site quality operation regarding
a. Contamination control operations and implementation of quality systems (e.g. lab investigation, OOS/OOT, deviation, CAPAs, QRM programs) as they pertain to QC, Microbiology and quality control programs.
b. Process validation, commissioning and qualification of new manufacturing areas, WFI system qualification, risk assessment, environmental control (quality/facility critical alarms), environmental qualifications and engineering needs.
c. Improve the trending monitoring and prompt statistical analysis on microbiological data to insure early notification of microbiological issues.
d. The oversight of microbiology lab operations including processing of sampling, testing, recording, data review, lab investigations and periodical data trending, excursions analysis and reporting.
e. Oversight and support for process, equipment and clean room validations including EM performance qualification, sterile gowning certification, media fill/challenge, and validations of autoclave, cartridge/Stopper/Cap washer, part washer etc.).
f. Advise in the development, and critically review equipment, process, utility/system and cleaning validation plans / protocols. Validation of methods and development of procedures and protocols, setting criteria and specifications for products regarding the sterile and contamination control.
g. Reviewed/comment IQ, OQ and PQ and any studies documentation. Review technical reports, qualifications, validation reports, and EM/Utility trend data, identify and implement CAPA to eliminate the reoccurrence of unexpected quality events.
10. Serve as technical expert during internal and external audits, HA regulatory inspections.
11. Provide technical guidance, professional development, and supervision the trainee growth. Contribute in contamination control and microbiology knowledge management via establishment of training material/format, delivering training course and coach the trainees.
12. Deliver training course internally and externally on contamination control of manufacturing process and environmental assurance relate to microbial awareness, aseptic technique, biosafety and environmental controls.
13. Implement GAP analysis for global requirement and local authority standard and take CAPA action
14. Manage the project related to contamination control and sterility assurance at site. Coordinate cross-function activity, making sure the implementation and deployment.
15. Own the sterility and contamination control relevant KPIs and continue the improvement.
16. Any other business and task responsibilities assigned.
Education / Experience A degree in Chemistry, Pharmacy and Biology or other related disciplines and a minimum of 7 years’ experience in environment monitor for sterile manufacturing process.
Technical skills &
Competencies / Language Must be problem solving oriented. Good English writing and spoken as well as a good knowledge of Chinese and international GMP are required.
(lead and others) Inspires continuous improvement & breakthrough thinking, display analytical &conceptual thinking.
Able to burden pressure, result driven