1) Looking after vendor management system of all primary and secondary Packaging materials.2) performing onsite audits of vendors and follow up for CAPA and compliance for the audit observations.3) Maintaining and updating of approved vendor list up to date.4) Preparation of annual audit schedule of packaging materials.5) Review and evaluation of changes done by vendor and evaluate the impact for product registration file.6) Follow up with vendor for all required vendor… Show more 1) Looking after vendor management system of all primary and secondary Packaging materials.2) performing onsite audits of vendors and follow up for CAPA and compliance for the audit observations.3) Maintaining and updating of approved vendor list up to date.4) Preparation of annual audit schedule of packaging materials.5) Review and evaluation of changes done by vendor and evaluate the impact for product registration file.6) Follow up with vendor for all required vendor qualification documents as per SFDA guidelines.7) Preparation of Annual Product Quality Review.8) To involve in QMS activities like change control, deviation, CAPA, incident etc9) To look after QA documentation section of quality documents for issuance, distribution, archival, retention and destruction.10) To maintain filing system of quality documents.11) To perform oversight activities in shop floor (Packaging area). Show less

1) Looking after vendor management system of all APIs, excipients and packaging materials.2) performing onsite audits of vendors and follow up for CAPA and compliance for the audit observations.3) submitting required documents to RA department for variation submissions, new product registrations and renewal of product registrations.4) Review of DMF and submission of the same to RA department for SFDA submission.5) Maintaining and updating of approved vendor list inline with SFDA… Show more 1) Looking after vendor management system of all APIs, excipients and packaging materials.2) performing onsite audits of vendors and follow up for CAPA and compliance for the audit observations.3) submitting required documents to RA department for variation submissions, new product registrations and renewal of product registrations.4) Review of DMF and submission of the same to RA department for SFDA submission.5) Maintaining and updating of approved vendor list inline with SFDA approved vendor list/sfda website.6) Preparation of annual audit schedule of APIs and packaging materials.7) Review and evaluation of changes done by vendor and evaluate the impact for product registration file.8) Follow up with vendor for all required vendor qualification documents as per SFDA guidelines. Show less

1) Preparation of Batch manufacturing records and Batch packing records2) Review of Batch manufacturing records and batch packing records before batch release3) Under taking Batch releases and packed stock verification4) Control on issue, retrieval and archival of documents5) Control on technical documents such as Change control, Deviation and Incident reports etc;6) Preparation of Annual product quality review (APQR).7) Issuing Process orders and release of batch… Show more 1) Preparation of Batch manufacturing records and Batch packing records2) Review of Batch manufacturing records and batch packing records before batch release3) Under taking Batch releases and packed stock verification4) Control on issue, retrieval and archival of documents5) Control on technical documents such as Change control, Deviation and Incident reports etc;6) Preparation of Annual product quality review (APQR).7) Issuing Process orders and release of batch through SAP.8) Releasing material indents through FOXPRO9) Preparation of SOP’s, and timely review 10) Preparation of Process validation protocols11) Controlling and checking in-process controls in Granulation, Compression, Coating, capsule filling, Blister packing, strip packing, dry syrup manufacturing and filling.12) In-process checks in vial filling and sealing for sterile dry powder injectables.13) Sampling of intermediates like blend, core, coated, and finished product and submitting to Quality control department14) Checking all log cards of each activity and online batch records. Show less

1) Controlling and checking in-process control.2) Preparation of BMR & BPR.3) Review of batch records online and for batch release.4) Reviewing BMR & BPR.5) Control on issue, retrieval and archival of documents.6) Control on technical matters in department (Deviations, Incident reports change control)etc.,7) All in-process checks in Granulation, Compression, Coating, Capsule filling, Packing, liquid manufacturing and liquid filling.8) Performing PSV before batch… Show more 1) Controlling and checking in-process control.2) Preparation of BMR & BPR.3) Review of batch records online and for batch release.4) Reviewing BMR & BPR.5) Control on issue, retrieval and archival of documents.6) Control on technical matters in department (Deviations, Incident reports change control)etc.,7) All in-process checks in Granulation, Compression, Coating, Capsule filling, Packing, liquid manufacturing and liquid filling.8) Performing PSV before batch release.9) Sound knowledge in investigating market complaints. Show less