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Quality Control Executive

0.00 to 1.00 Years   Pune   11 Aug, 2023
QUISCON BIOTECH
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaPharmacist / Medical Representative
EmploymentTypeFull-time

Job Description

    Roles:To work in Quality Control activities of the Lab with regard to Testing of Raw Material, In process, Finished Products, documentation and quality management system requirements at Quality Control lab. To ensure that the requirements of MDR, ISO 13485, ISO 3826, USFDA QSR CFR Part 820 and such other international standards are implemented and maintained. Handle regulatory and customer audits and customer requirements related quality and other statue.Responsibilities:Ensure all phases of a manufacturing and other handling process meets the standards or requirements of the quality plan including in-process check.Play an active role in all stages of the production process (Raw Materials Analyst), during production itself (In Process Analyst) or at the end of manufacture (Finished Product testing).Timely completion of all experiments according to established Standard Operating Practices (SOPs), and also Good Laboratory Practices (GLP) or Good Clinical Practices (GCP), ISO/ EN standards for highly regulated industries.Basic lab-work and use of chemical/pharma/microbiology testing equipment and processes.Prepare technical documents that report the results of their lab work. (Batch release records, sterility data, stability data, validation data)Responsible for minor equipment troubleshooting, calibration and repair.Establish specifications for conducting assays and writing standard operating procedures.Follow practices/ documentation pertaining to MDR and all applicable statutory requirementsResponsible for QMS elements viz. Change control, Deviation, CAPA etc. and its tracking for closure.Monitoring of supplier performance/ compliance documents (Audit response/CAPA) and support the team in taking informed decision on approving the supplier/vendor/service providersQualifications and Skills Necessary:Masters degree or equivalent (or higher) in chemistry/ plastic engineering/ polymer science/ microbiology or Biotechnology.Ability to work both in a team or individually and good mathematical skills are all required.Proven knowledge of methods/techniques of medical devices. ISO 3826Experience in Medical devices QMS ISO 13485 and wet lab/ instrumentation.Hands on experience in EN-ISO 13485, EU MDR, CE marking, USFDA QSR CFR Part 820 and such other international standards.Experience in handling audits/ inspection of Indian medical devices rule requirements.Interested to apply can share CV or call/whatsapp tohidden_mobile

Keyskills :
clinical monitoringclinical researchclinical trialsclinical pharmacologyclinical research associates

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