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Company Name : Axio Biosolutions
Location : Ahmedabad, Gujarat
Position : Quality Control Executive
Job Description : DesignationQuality Control Executive
To land this job you will needBe passionate about Quality function in the medical devices industry.Should be good in communication, effective written, and presentationExcellent analytical skills, result oriented and team worker.Awareness and handling of QMS related requirements such as Change
management, Deviation, OOS, OOT.Knowledge of Stability study requirement.Understanding of GMP, GLP, GDP, ISO13485, 21 CFR related
requirements.Understanding of Terminal sterilization related requirements.Ability to work in flexible working hours based on the business requirement.Ability to work effectively and collaboratively, across functions.Experience in audit handling will be an advantage.
Primary Job FunctionThe successful candidate will be responsible to perform testing related to Micro /Chemical as per Company’s procedures
Experience RequiredMinimum 2 years of experience in Micro and QC testing in the medical device/Pharma domain.
Core ResponsibilitiesTo perform and review micro related testing. Majorly Sterility, Environmental monitoring, personal monitoring, gowning monitoring, bioburden testing of product and packaging material, Bacterial Endotoxin tests (BET), etc…To know Gamma irradiation validation requirement, validation of Bioburden study and other method validation requirements.To perform the activity in GMP/GLP environment and awareness of ISO13485, 21CFR requirements.Document preparation and review of Quality control, micro related activity.
For more information, Mail to firstname.lastname@example.org or Call +91-XXXXXXXXXXDisclaimer: This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at anytime at the sole discretion of the Employer.
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