Zydus Biologics Hiring For QC/ QC Micro/ IPQA/ QMS/ Analytical/ Documentation

Zydus Biologics Hiring For QC/ QC Micro/ IPQA/ QMS/ Analytical/ Documentation

Zydus Biologics Job Vacancy Details: 

Inviting candidates for Executive/ Senior Executive post in Quality Control/ Quality Assurance for Zydus Biologics (Zydus Biotech Park) at Ahmedabad

For all the positions mentioned candidates should have 2-6 years of experience and should be from MSc-Biotech/ M.Sc Micro/ M.sc Biochemistry background.

1) Quality Control

QC Chemical: Candidates should have experience in analysis of protein analysis/ instrumentation, molecular biology, bioassay and lab activity related documents They would be responsible for reviewing all the documents, test reports. calibration reports records, logbooks and formats in relation to the activity of protein analysis/ Instrumentation, molecular biology, bioassay and filling.

They would also be responsible for carrying out investigation of incident, deviation and 005 generated during laboratory analysis.

QC Microbiologist: Should be responsible for environmental monitoring (air

sampling settle plate, surface monitoring and personnel monitoring) / water testing/ bioassay/ BET test/ MLT/ sterility testing etc.

2) Quality Assurance

IPQA: Candidates should have experience in OA oversight (POA) related activities for drug substance manufacturing along with handling of process validations. batch release activities, cleaning validations process investigation, 005 / 00T investigation, change control, deviation, CAPA and QMS activities.

QMS: Experience in QMS related activities like failure investigation, quality events handling and investigations, change control, market complaint, conducting self- inspection, APQR, ODS/ QOT trending etc

3) Quality Assurance

QA Analytical: Should have experience in reviewing of analytical batch docket/ reports, stability protocols and data sheets, laboratory investigation, reviewing and involvement in investigation of 005, 00T, OOC results, handling of incidents deviations, Change Controls in the laboratory along with reviewing of all types of calibration/ qualification documents and reviewing / oversight implementation of all lab standard operating procedures.

Documentation cell: Experience in handling and controlling of various GMP

documents (issuance / control / retrieval / archival).

Candidates should be responsible for retaining all master / executed documents in document storage room with adequate indexing and keeping ready all the documents for the regulatory audit(s).

For all above positions, candidates having exposure to regulatory requirement of documentation and cGMP/ GLP is essential

The last date for applying is 20th September 2023.

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