To ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards and all such international quality standards in the plant.
Manage the microbiology function or all aspects of microbiological and related services in support of sterile Injectable product manufacturing plant operations.
To ensure the process of Technology Transfer Dossier (TTD) acceptance to the plant and to work out the manufacturing and availability of the product without delays.
To ensure that every batch of product meets the defined standards for strengths, identity, safety, purity and quality by various system-driven approaches.
To ensure the implementation of Internal Quality Audit (IQA) schedule for manufacturing facilities of the plant.
To participate in CAPA meetings and suggest corrective or preventive actions.
To take corrective and preventive actions by performing root cause analysis for complaints and deviations in order to minimize chances of such occurrences.
To appoint the qualified staff for technical function and ensuring their technical and overall development through systematic training processes and reviewing their performance periodically.
To review & approve the Standard Operating Procedure (SOP) according to the current regulatory requirements.
To approve Master Protocols.
To approve the yearly calendar such as calibration and Performance Qualification (PQ) Calendars.
To approve draft reply for International Regulatory Affairs (IRA) queries received.
To approve master drawing related to the facility and process.
To review performance of QA department at regular frequency conducting reviews and suggest improvement areas.
To prepare and Finalized replies for IRA queries received.
Report, investigate, and resolve any QMS incidents in the process, system, facility or documents associated with non-conformances related to the microbiological aspects such as sterility, bioburden, endotoxin, environmental monitoring, etc
Provide microbiological sampling, testing, and monitoring to assure quality of materials, components, in-process products, finished products, and retained/stability samples, including:
a. Media Preparations
b. Plate Observations
c. Colony identification
d. Isolate Library
e. Culture Prep and Maintenance
f. BET testing
g. Sterility testing
h. Growth promotion testing (GPT)
i. Bioburden testing
j. Environmental Monitoring
We are an Executive Search & HR Consultancy is a young emerging organization... established by HR professionals with the objective of providing comprehensive staffing & Manpower solutions to the organizations.
We believe in understanding the clients business, so as to proactively align the HR process with the business needs of our clients. We believe in providing a solution for all the HR related activities. Read full description