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Executive, Quality Control

Executive, Quality Control – Aurangabad

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science bringing creative ideas, products, and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity.

The Executive, Quality Control Plans, coordinates, and performs routine and complex Microbiological testing in compliance with laboratory test methods and procedures to support the manufacturing and timely delivery of product to customers. The individual also executes activities of Quality Control, Microbiology section activities to ensure continuous production of products consistent with established Quality & Regulatory standards by performing the assigned duties and responsibilities.

Major Duties & Responsibilities:

Perform applicable Compendia testing, Microbiological Test Method validations/verifications.
Microbiology testing, reports review when thorough training has been completed under the guidance of supervisor.
Initiation and participation during investigations for non-conforming laboratory test results, laboratory incidents and out of specifications / OOT.
Ensure Troubleshooting methodology are applied as per requirements and instrument problems are rectified on timely basis for smooth functioning of Microbiology tests and microbial evaluation.
Perform Microbiological tests including Bioburden test, Water tests, MLT, Bacterial Endotoxin Tests, Microbio-stasis tests, Sterility tests, GPT, Environmental Monitoring, Personnel Monitoring, Specified MO’s tests, and enumeration using aseptic techniques and Microbiological skills. Media preparation and media/chemicals inventory management.
Plan and execute activities related to Microbiological SOP preparation, protocols, reports preparations including instrument validations (e.g. Autoclave, DHS) , area qualifications (Classified areas), Microbial evaluation of sterilization process, Area qualifications (HVAC),  Hold time studies of sterilized media, Cleaning and disinfectant validations, sterilized garments, and of other relevant process and practices. Basic knowledge sterilization processes.
Operating in accordance with current GxPs with regard to documenting, testing and maintaining accurate laboratory records. Complies with all training requirements to perform duties of the job.
Support and execute activities related to Microbiology Projects, Change Controls, Actions and  Effectiveness Monitoring.

Performing calibrations, validations and annual /maintenance of laboratory Instrument life cycle management according  to current SOPs.
Assisting in various other duties which contribute to the organization and function of the laboratory, and as assigned by Supervisor.
Ensuring personal and company compliance with all local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Co-ordinate and support in Biohazard safety and its management.

Trending and analysis of statistical data related to microbiology activities to determine present standards and establish proposed quality and reliability expectancy.
Carries out duties in compliance with all regulations and guidelines including MDR and Food & Drug Administration (FDA). Complies with all company and site policies and procedures. Follows all applicable aspects of the site environmental management system.

QUALIFICATIONS
Qualifications:

Education: Graduate or Postgraduate in Microbiology or Life Sciences

Required Years of Related Experience:  3-6 years’ experience in Microbiology; Local Food and Drugs Administration approved preferred.

Required Knowledge, Skills, and Abilities (Uncompromised requirements for the role) :

Knowledge of GxP Documentation and of following areas like Test Method and Specification, Instrument operation procedure, current regulations. Departmental SOP’s, Report writing / Data analysis, OOS / NC procedures and Data Integrity issues.
QMS: In depth knowledge of tools for investigation of OOS / NC, Audit trail reviews and capabilities of analysing its impact assessment.
Cross Functional coordination: Coordination skills with all stake holders.
Instrumentation and Analysis: Overall knowledge of Microbiological Instrumentation and analysis.
Operational Excellence: Basic knowledge of Project management, Analytics & Problem-Solving skills, Technology &  Data Management, Decision Making, Knowledge Management.

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