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4.0 - 6.0 years
4 - 6 Lacs
Jammu
Work from Office
Role & responsibilities Job Responsibilities knowledge on Quality control function like FP/RM/PM/Stability of Solid dosage forms. good knowledge on QC Instrumentations trouble shooting of QC instruments like Auto titrator, HPLC, GC etc. 21CFR part 11 compliance and Computer system validation Investigation like OOS, OOT, events and deviation management. LEAN management and Good presentation skill exposure to Regulatory Audit handling and management review of SOPs versus practices for gap analysis. Trending of QC data and deriving action plan for compliance readiness Preferred candidate profile B.Pharma / M.Sc with 4 to 6 yrs experience as QC investigator. good in english verbal and written co...
Posted 2 months ago
15.0 - 25.0 years
15 - 25 Lacs
Bilaspur, Uttar Pradesh, Uttar Pradesh, India
On-site
To do planning and scheduling for annual preventive maintenance and calibration of all electrical and instrument installations in the Plant To attend and timely response for all emergency breakdowns of electrical and instrument installations in the plant. To ensure tentative schedule for earthing audit of all electrical installations and its execution, also scheduling & implementations of other GMP requirements. To ensure implementing compliances of computer validation as per 21CFR part 11, GAMP-5 and other relevant guidelines. Ensure the GMP compliance in calibration lab and instrument function. To inspect and approve the electrical and instrumentation items received in Engineering Stores. ...
Posted 3 months ago
4.0 - 9.0 years
4 - 9 Lacs
Hyderabad
Work from Office
Handling of all Vendor Management related activities including qualification of Vendors, Service Providers, Contract Manufacturing and Contract Testing Laboratories across R&D, API and Formulation units of Biological E, pharma divisions. To perform On-site audits as part of vendor audits, contract testing laboratories, contract manufacturing, external service vendors qualifications. Initiation and Review of Quality Management Systems (QMS), including Change controls, Deviations, Investigation reports and CAPAs. To perform Risk assessments related to Vendor, Contract Testing Laboratories and Contract Manufacturing and Service Provider qualification related activities. Preparation & review of ...
Posted 3 months ago
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