Zydus – Interview for Vaccine QC & QA on 7th July, 2024@ Hyderabad
WALK-IN-INTERVIEW FOR ZYDUS LIFESCIENCES LIMITED @ HYDERABAD
We are hiring for Vaccine Technology Centre, Ahmedabad
Quality Control: Executive / Sr. Executive / Assistant Manager / Deputy Manager
Experience: 4 to 12 years
Educational Qualification : M.Sc / B.Tech / M.Tech in Biotechnology
Quality Assurance: Sr. Executive / Assistant Manager / Deputy Manager
Experience: 8-12 years
Educational Qualification: M.Sc / B.Tech / M.Tech in Biotechnology.
QC: Executive / Sr. Executive / Assistant Manager / Deputy Manager
Job Description :-
Virology QC
- Experience in techniques such as cell culture based assays, Virus titration, ELISA, RT-PCR and biochemical assays required.
- Responsible for review and to execute analytical plans for Viral vaccine testing.
- Additional experience in analysis of bacterial or recombinant vaccine testing preferred.
- Analyst shall be well versed with cell based assays, Virus titration, RTPCR and immuno-chemical assays.Instrument knowledge on pH meter, Analytical balance, Karl Fischer, Real time PCR and ELISA
- Knowledge in calibration and qualification of equipment and instruments.
Bacterial QC
- Analyst shall be well versed with Bio-chemical assays, immuno-chemical assays and HPLC based assays.
- Experience in analysis of Polysaccharide vaccines/ Bacterial vaccines are preferred.
- Instrument knowledge on UV spectrophotmeter, ELISA reader, HPLC, UFLC, Kjeldahl and IC-chromatography are preferred
- Experience in handling QMS elements like OOS, OOT, change control and deviation are added advantage.
Knowledge in calibration and qualification of equipment and instruments. - To perform/Monitor activities in compliance with GMP/GLP.
Experience in handling stability studies and maintaining Good documentation practice.
Role shall require to coordinate with maintenance department or third party lab as and when required.
QMS :- Candidate shall be well versed with QMS, Responsible to initiate Change Conrol, Incident, Deviation etc.. Coordinate and conduct required investigation for any reported OOS results / deviation / OOT results / product recall / market complaints / stability failures etc. and prepare detailed investigation report. Responsible for Execution of Computer system validation (CSV), (IQ, OQ, PQ) online verification of User privileges matrix and other Information technology related Documents activity for improvement of Compliance system and reducing compliance audit observations.
RM/PM
Minimum 4-5 years of Raw and Packing material analysis in Quality control department, Instrument knowledge on pH meter, Conductivity meter, Analytical balance, Karl Fischer, UV, TOC, Auto titrator, Analyst shall be well versed with operations in LIMS & SAP, Knowledge in calibration and qualification of equipment and instruments.
Qualification: M.Sc Chemistry
QA: Sr. Executive/ Assistant Manager / Deputy Manager
Job Description :-
Manufacturing (IPQA)
1. To ensure shop floor compliance to cGMP and GDP and facility/equipment up keeping.
2. Responsible daily oversight of document destruction process.
3. Responsible for quality oversight of personnel, process and practice to meet the cGMP and compliance requirement.
QA: Sr. Executive/ Assistant Manager / Deputy Manager
Job Description :-
Manufacturing (IPQA)
- To ensure shop floor compliance to cGMP and GDP and facility/equipment up keeping.
- Responsible daily oversight of document destruction process.
- Responsible for quality oversight of personnel, process and practice to meet the cGMP and compliance requirement.
Sterility Assurance
- To ensure the procedure is followed at all the critical production stages to maintain the sterility of the components and products.
- Responsible for evaluating sterility assurance of process, equipment and personnel.
- To monitor the aseptic practices during media fill run; to evaluate and suggest improvements in practice.
Deviation and Process Investigation
- To participate in an investigation plan in consultation with department head, QA section in-charge and shall conduct investigation & submit their findings to respective department Head and QMS team.
- To find root cause or contributory factors for probable cause of OOS/ OOT/ process failure.
- To draw meaningful conclusions based on trend, consider similar nature of deviations reported for other batches of same product, other products and other batches.
- To conduct investigation in consultation with other department(s).
Technology Transfer, Process Validation, Cleaning validation
- 1. To verify the data / information provided in the Technology transfer document for its completeness, relevance and scientific basis, as per applicable guidelines.
- 2. To prepare and review the Process/Cleaning Validation Master Plan.
- 4. To ensure that SAP/LIMS related activities such as code creation, BOM creation, specification uploading etc. is completed.
- 5. To review the deviation / incidences, Change Control proposals for facility, equipment, equipment shifting and evaluate Validation requirements through risk assessment.
- 6. To provide information required for the Preparation of Annual Product Review with regards to Validation.
- 7. Review and approval of BMR/BPR of Engineering Batch.
- 8. Review of recommendation given for manufacturing of PPQ batches based on learning from Engineering batch.
- 9. Review and Approval of Engineering Batch Report.
- 10. To execute technology transfer activity from site to site as per site SOP.
- Review and approval of cleaning validation/verification protocols and reports as well as assessment and evaluation of study in co-ordination with production/engineering and quality control department
Job location: Ahmedabad, Gujarat
Date: 7th July, 2024 (Sunday)
Time: 9 am to 5 pm
Venue: Greenpark Hotels, Hyderabad, Begumpet Rd, Leelanagar, Telangana 500016.
APPLY THROUGH LINK https://zydusgroup.darwinbox.in/ms/candidate/careers/a667932fe8ffd6/custom_source/WalkIn%20Hyderabad%20for%20vaccine%20Biotech%20experience%20QC%20QAndidate
