Experience Inc. Jobs

Quality Control Analyst II

Date: Aug 16, 2024

Location:

Gajraula, India, 244235

Company: Teva Pharmaceuticals

Job Id: 57101

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

How you’ll spend your day

• FDA Approved in Microbiology.(should be Preferred)

• Investigations of Deviations, OOS, OOT, Alert Limit, Action Limit and Atypical Analytical Test results, Instruments errors, Change Control and temporary changes.

• Responsible for preparation of quality management system documents.

• Raising the purchase requisition for arranging the items related to microbiology

• Preparing the document and STP related to microbiological analysis

• To execute the protocol and report to perform the validation/study activities.

• Instrument Calibration, Preventive maintenance and Malfunctioning Management related to microbiology.

• Ensure Adequacy and timely completion of Investigation, Change controls, and CAPA’s of all above areas.

• Responsible to explain above area in case of customer, regulatory, any other external or internal audits.

• Overseeing the operations of the laboratory on a day-to-day basis, per shift, to ensure GXP in laboratory.

• Should be skilled to handled regulatory inspection.

• To ensure corrective and preventive actions are implemented and are effective.

Technical skills required of below tests

• Bacterial Endotoxin Test (Gel Clot &Kinetic Method).

• Sterility Test by Direct Inoculation & Membrane Filtration Method & Validation.

• Microbial Limit Test & Validation.

• Microbial Analysis of Water. (WFI, PW, RW, RO, SW, PSC).

• Identification of Isolates

• Culture Suspension preparation 10 – 100 CFU/ml.

• Microbial Culture Maintenance.

• Growth Promotion & Inhibitory Test of Prepared Culture Media.

• Environment Monitoring Program – Settle plate, Air Sampling, Surface monitoring (By swab and contact Plate), Personnel monitoring in Aseptic Area.

• Hold Time Study of Sterilized Garments.

• Disinfectant Efficacy Test.

• UV Efficacy Test.

• Media fill Validation, Disinfectant validation, Preservative efficacy test, Preparation of Environment Monitoring & Water Trends.

Your experience and qualifications

Experience: 10+ Years of relevant experience.

Qualification: MSc Microbiology

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

EOE including disability/veteran