Skills

Present Job Responsibilities (QA- Quality Compliance & QMS):

• Handling of Investigations, Deviations, Incidents, OOS and OOT- Review, Evaluation, Follow up, Closing and Implementation.
• Handling of CAPA – Review; Follow up, Closing and Implementation.
• Reviewing data in context to Data Integrity and ALCOA+ principle.
• Review and Evaluation of Change control documents.
• Review of Quality Department documents as per the procedures and ensuring compliance.
• Coordinating with cross functional department for closing of QMS related documents.
• Conducting internal audits to assess compliance with regulations, guidelines and operating procedures.
• Conducting training sessions on cGMP to increase the awareness on Quality, GxP and Data integrity aspects across the respective functions.
• Compliance to organization integrity and safety principles at all stages of operations.
• Participating in external (Regulatory and Non-regulatory) audits.
• Review of SOP’s, STP’s and Raw material specifications.
• Review of Equipment’s qualification, calibration and validation data.
• Review of Validation protocols & reports.

Job Responsibilities handled in Microbiology Laboratory

• Managed all microbiology lab operations for analytical and documentary compliance.
• Managing and supervision of microbiological tests, designing protocols as per regulatory requirements.
• Detecting and analyzing failures of microbiological tests, investigation and implementing CAPA for the same.
• Managed the scheduling for environmental monitoring of manufacturing site.
• Training and developing the laboratory personnel for continuous improvement of laboratory efficiency and productivity.
• Managed lab equipment validation, calibration and maintenance activities.
• Microbiology tests executed and supervised:
• Water sampling and microbiological analysis of water samples (Process water, Purified water and WFI).
• Environmental monitoring of Clean rooms.
• Media preparation, Growth promotion test and Media suitability tests.
• Sub culturing, preservation, maintenance and purity check of reference cultures.
• Isolation and identification of microorganisms using Vitek 2 Compact identification system.
• Sterility testing of in process samples and finished products using open and closed system.
• Participated in process simulation studies - Media Fills (Sterile formulations).
• Population determination of Biological Indicators.
• Container Closure Integrity Testing – Microbiological method.
• Bacterial Endotoxin Test and Microbial Limit Test.

• Microbiology validations executed and supervised:
• Sterility Test Method Validation.
• Water System Validation.
• Validation of Disinfectant Efficacy.
• Shelf life study of sterile media.
• HVAC Validation.
• Equipment validations (Incubators, LAF’S, BSC, Autoclave and other lab equipment’s).
• Microbiology miscellaneous validation studies.

Key Result Areas:

• Successfully handled set-up of Microbiology Lab in two Green field projects.
• Played a pivotal role in development and implementation of microbiological tests with active participation.
• Handled preparation of in-house SOPs, qualification of equipment, generation of reports, reviewing of documents.
• Faced internal / external audits with respect to system compliance, documentation and regulatory requirements.

Competencies

• Leadership:
• Communicating clearly and effectively.
• Adapting to individuals and situations when interacting with people.
• Receptive with an opened mind.

• Document Management:
• Analyzing data as per ALCOA+ principle.

• Problem Solving:
• Adopting a precise approach to problem solving within a regulatory context.
• Making realistic and appropriate decisions.

• Quality Assurance:
• Ensuring product integrity and compliance based on standards and regulation.

Monitoring compliance with cGMP, regulatory requirements and company standards.

Refrences