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Quality Head/QA Head

15.00 to 18.00 Years   Noida, Chennai, Hyderabad, Gurugram   30 May, 2022
WHITESLIPS GLOBAL SERVICES PRIVATE LIMITED
Job LocationNoida, Chennai, Hyderabad, Gurugram
EducationNot Mentioned
SalaryRs 20 - 30 Lakh/Yr
IndustryPharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    Roles and Responsibilities1. Manage day to day activities of the pharmaceutical manufacturing plant2. Review and Approval of master documents, BMR, BPR, RMS, PMS, FPS and MOA.3. Review and Approval of change controls, deviations, SOPs, and destruction certificates.4. Monitoring of all the third-party and loan license products.5. Liaise with production planning, purchase, export, logistic, distribution, and registration department to achieve the production/ dossier submission targets.6. Plan and perform vendor/ third party/ loan license/ warehouse audits7. Provide regulatory support and guidance for application of license.8. Handling of complaints, investigations and initiation of CAPA.9. Manage Vendor Development process for raw materials10. Review of Process Validation/ Stability Protocols.11. Loan License and Third Party Product Development.12. Be a part of New Product Development team and give suggestions/ inputs for the development of products.13. Taking overview of our own factories, third party and loan license locations.14. Monitoring of Batch Release process for domestic as well as all export products.15. Review of stability data.16. Provide support to analytical team for analysis of raw materials and finished products.17. Prepare, submit and monthly review meetings18. Handling of the consumer queries19. Maintenance of the documents like price list, product list etc.20. Review and approval of First Lot to Sales products21. Monitoring of ERP entries for raw and packaging materials and finished products.22. Trainings to all the concerned departments on the systems/ SOPs etc.23. Adequate knowledge on current GMP/ GLP/ FSSAI guidelines24. Handling of registration queriesDesired Candidate ProfileResponsible for Quality Assurance & Control activitiesRich experience in implementing Quality Management systemsShould have experience in pharma formulationFluent Communication Skills

Keyskills :
quality auditquality managementpharmaceutical manufacturingquality analysisquality assuranceteam management

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