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  • Top Management Job Role Head/VP/GM-Business Development Keyword Head API Active Pharma Bulk drug Manufacturing roduction Maintenance Job Type Permanent

  • * Issuance & retrieval of the BMR, BCR, BPR & all control documents * Preparation of APQR * Exposure to Handling of Validation / Qualification / Change control / Deviation / OOS and Market complaints * Records as per cGMP / Regulatory requirements * Preparation of records/documents as assigned by the senior in QA departments * Preparation of QA SOP and any other documents work relevant to department. * Sampling/sealing of ...

  • * LIMs master creation, LIMS master modification to implement * SAP QM Master,SAP QM master modification correspondingly * Preparation and revision of specification, STP,GTP,SOP * Periodic review of specification, STP, GTP, SOP * CAPA implementation

  • * LIMs master creation, LIMS master modification to implement * SAP QM Master,SAP QM master modification correspondingly * Preparation and revision of specification, STP,GTP,SOP * Periodic review of specification, STP, GTP, SOP * CAPA implementation

  • * Issuance & retrieval of the BMR, BCR, BPR & all control documents * Preparation of APQR * Exposure to Handling of Validation / Qualification / Change control / Deviation / OOS and Market complaints * records as per cGMP / Regulatory requirements

  • Position Summary: Accountabilities: - Compilation of Drug Master Files, Registration Dossiers & Technical Data Packages/Open Parts for In-House developed APIs manufactured at In-House API manufacturing sites and ensuring their updation - Preparation of Regulatory Amendments / Variations

  • cGMP & regulatory requirement and planning accordingly. 4. Maintaining cGMP in manufacturing area and training of colleagues. 5. Preparation of validation protocols i.e. IQ, OQ and PQ of Equipments & facility. 6. Documentation related to USFDA, Compliance to External & internal Audits. 7 ...

  • cGMP & regulatory requirement and planning accordingly. 4. Maintaining cGMP in manufacturing area and training of colleagues. 5. Preparation of validation protocols i.e. IQ, OQ and PQ of Equipments & facility. 6. Documentation related to USFDA, Compliance to External & internal Audits. 7 ...

  • cGMP & regulatory requirement and planning accordingly. 4. Maintaining cGMP in manufacturing area and training of colleagues. 5. Preparation of validation protocols i.e. IQ, OQ and PQ of Equipments & facility. 6. Documentation related to USFDA, Compliance to External & internal Audits. 7 ...

  • cGMP & regulatory requirement and planning accordingly. 4. Maintaining cGMP in manufacturing area and training of colleagues. 5. Preparation of validation protocols i.e. IQ, OQ and PQ of Equipments & facility. 6. Documentation related to USFDA, Compliance to External & internal Audits. 7 ...

  • cGMP & regulatory requirement and planning accordingly. 4. Maintaining cGMP in manufacturing area and training of colleagues. 5. Preparation of validation protocols i.e. IQ, OQ and PQ of Equipments & facility. 6. Documentation related to USFDA, Compliance to External & internal Audits. 7 ...

  • cGMP & regulatory requirement and planning accordingly. 4. Maintaining cGMP in manufacturing area and training of colleagues. 5. Preparation of validation protocols i.e. IQ, OQ and PQ of Equipments & facility. 6. Documentation related to USFDA, Compliance to External & internal Audits. 7 ...

  • Position Title: RESEARCH MANAGER Educational Qualifications M. Sc. (Organic Chemistry)/ M. Pharm (Medicinal chemistry) Position Summary: Accountabilities: - Compilation of Drug Master Files, Registration Dossiers & Technical Data Packages/Open Parts for In-House developed APIs manufactured

  • #Initiation and implementation of GMP #To review and approve Standard Operating Procedure (SOP), Batch Manufacturing Record (BMR), Change control, Deviation controls, OOS, OOT investigation & report and distribution of revised documents. #To co-ordinate for technology transfer #To evaluate the reprocessing and reworking procedures #Finished product release record verification #Regulatory document complies ...

  • #Initiation and implementation of GMP #To review and approve Standard Operating Procedure (SOP), Batch Manufacturing Record (BMR), Change control, Deviation controls, OOS, OOT investigation & report and distribution of revised documents. #To co-ordinate for technology transfer #To evaluate the reprocessing and reworking procedures #Finished product release record verification #Regulatory document complies ...

  • #Initiation and implementation of GMP #To review and approve Standard Operating Procedure (SOP), Batch Manufacturing Record (BMR), Change control, Deviation controls, OOS, OOT investigation & report and distribution of revised documents. #To co-ordinate for technology transfer #To evaluate the reprocessing and reworking procedures #Finished product release record verification #Regulatory document complies ...

  • We have very urgent opening for Project Manager with reputed API / Bulk Drugs manufacturing company near Vadodara. We are looking for candidate with BE - Mechanical having 10-15 years of experience in project department with any reputed company

  • Sentinel, Codesoft) Oracle Work Flow / Business Event Oracle Alerts Shell Script / Unix commands JSP and OAF customization ( any knowledge on this is added advantage) Strong knowledge of data conversion and Interface/Integrations with all open interfaces & public API’s Oracle Application Object _ Oracle Modules Track: (Expertise in several or all of the following modules is required) Manufacturing (INV, BOM,WIP ...

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