bpr

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Job Description Buffer preparation for small and large-scale operations, IPQC operation of buffer and protein intermediate samples. ▪ CIP of chromatography systems, TFF systems and process vessels. ▪ SIP of TFF systems and process vessels. ▪ Operation of chromatography systems, TFF systems, Virus Filtration System, DS filtration for protein...

Key Responsibilities: • Ensure smooth product/batch changeover and line clearance in accordance with Standard Operating Procedures (SOPs). • Coordinate with engineering and service departments to ensure line efficiency. • Manage batch records and online documentation (BPR) accurately. • Verify that packing materials and tablets are available and...

Job Description • Buffer preparation for small and large-scale operations, IPQC operation of buffer and protein intermediate samples. • CIP of chromatography systems, TFF systems and process vessels. • SIP of TFF systems and process vessels. • Operation of chromatography systems, TFF systems, Virus Filtration System, DS filtration for protein...

Job Description Buffer preparation for small and large-scale operations, IPQC operation of buffer and protein intermediate samples. ▪ CIP of chromatography systems, TFF systems and process vessels. ▪ SIP of TFF systems and process vessels. ▪ Operation of chromatography systems, TFF systems, Virus Filtration System, DS filtration for protein...

Job Description • Buffer preparation for small and large-scale operations, IPQC operation of buffer and protein intermediate samples. • CIP of chromatography systems, TFF systems and process vessels. • SIP of TFF systems and process vessels. • Operation of chromatography systems, TFF systems, Virus Filtration System, DS filtration for protein...

Job Description: Production : • To check the labels of raw material, packing materials and solvents before usage. • To maintain storage conditions of raw material/intermediates in plant. • To maintain process conditions for batch as per BPRs. • To take instruction from shift Incharge/managers for batch charging / monitoring & follow up. • To...

1. Senior Operator to Apprentice-Packing shall report to Sr. Officer to Jr. Officer- Packing.2. Responsible for cleaning and operation of equipments, instruments as per respective Standard Operating Procedure (SOP).3. Responsible for performing packing operations as per respective BPR.4. Responsible for performing in process tests as per respective BPR.5. To...

Role & responsibilities  : Review of all QMS documents related to regulatory submissions Prepare status of all documents related to submission Co-ordinate with all stakeholders of plant for collection of documents Provide all regulatory documents to HO-RA for submission. Evaluation of change control, deviations and out of specifications. Review of...

Trainee Operative Technician :Senior Operator to Apprentice-Packing shall report to Sr. Officer to Jr. Officer- Packing.Responsible for cleaning and operation of equipments, instruments as per respective Standard Operating Procedure (SOP).Responsible for performing packing operations as per respective BPR.Responsible for performing in process tests as per...

Job Description: Shop-Floor QA / GMP Compliance Perform routine QA oversight of API manufacturing and packaging operations. Ensure manufacturing activities are performed according to approved SOPs, BMR/BPR, specifications, and GMP requirements. Conduct line clearance and area/equipment verification before commencement of manufacturing...

Job Description Preparation & Review of SOP’s of QA system and review / approval of SOP’s of other departments. Review of master BMR/BPR of commercial and exhibit batches. Review of BMR / BPR, scale-up and placebo batches. Review of executed BMR/BPR of commercial and exhibit batches for batch release. Issuance, Retrieval & Destruction of SOP’s, STP,...

Description: Operate and monitor manufacturing equipment and Instrument used in various stages of API production, such as reactors, Centrifuge, Dryer, Miller, sifter etc. Maintaining accurate records and documentation of production activities, including batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR) records,...

To update Tire-1 display board update, gaps, break downs, analysis, reason for gaps, any issue for next 24 hrs BPR review which process completed with follow data integrity guideline. Documentation should be - Attributable - Legible -Contemporaneous - Original - Accurate Prepare Purchase requisition and coordinate with purchase department for procurement of...

Role & responsibilities To take plant round and monitor production activities at shop floor. To prepare appropriate Quality related documents like SOP, BMR, BCR, BPR etc. To review BMRs, BCRs, and analysis records before release of API. To perform sampling of API's and maintain its records. To maintain control samples of API and its records. To perform and...

Job Description: • Responsible for review, tracking and closing of deviation, change control and CAPA in LIMS. • Responsible for participating in investigation along with cross functional team to find out actual root cause of incident or deviation. • Responsible for review and assign number to Deviation, Change control, CAPA when required...

DescriptionDescription:Operate and monitor manufacturing equipment and Instrument used in various stages of API production, such as reactors, Centrifuge, Dryer, Miller, sifter etc.Maintaining accurate records and documentation of production activities, including batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR)...

Job Description:  Position   / Job TitleTechnician   – OSD Packing (Secondary)DepartmentOSD   packing Reporting   ToOfficer   – OSD packing LocationAmbernathYears   of Experience4   -7 years Dosage   FormSolid   Oral Job   Responsibilities / DeliverablesSecondary Packing OperationsSets,   Operates and monitors Secondary packing machines such...

Job Description: Documentation: • To prepare SOP’s/ URS/ BPR/ Protocol/ Investigation report for regulatory compliance as per available procedure/practice. • Ensure that all documents / records required for Regulatory Compliance are maintained properly. • Ensure old records are archived properly and are retrievable. • To check online filling...

Job Description Act as shift supervisor, lead, train and mentor the downstream team. Buffer preparation for small and large-scale operations, IPQC operation of buffer and protein intermediate samples. CIP of chromatography systems, TFF systems and process vessels. SIP of TFF systems and process vessels. Operation of chromatography systems, TFF systems,...