Unison Pharmaceuticals Walk In Interview 2023. Unison Pharmaceuticals Notification full details below..Interested and eligible candidates can attend interview on scheduled time and venue.Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality and most affordable medicines across the nation. With more than 4 decades of medical service to the society, Unison is today one of the fastest growing company in Gujarat State.
- Post Name: Officer / Sr. Officer / Executive/Sr.Executive
- Department: QA
- Qualification: Msc,Bpharm,Mpharm
- Experienced: 1-7 years
Job Description: Greeting from Unison Pharmaceuticals !!!!!
Important Details :
- Location: Ahmedabad( Moraiya )
- Post of date:03/10/2023
- Selection Process: The selection will be on the basis of Interview.
Time: 09:30 AM to 04:30 PM
Unison Pharmaceuticals Pvt. Ltd.
C-6,7,8.9-Steel Town, Behind-HOF, Village-Moraiya, Ta Sanand, Dist Ahmedabad 382213
Interested candidates send their resume to email@example.com
Contact – Manisha Rajput ( 7575010163 )
Unison Pharmaceuticals is urgently seeking talented MFG and Packing IPQA, Documentation, Equipment Qualification, Vendor Qualification, LAB QA, and QMS professionals for our OSD Quality Assurance team. Apply now to become a part of our team.
Experience: 3-7 years
Job Roles: Mfg and Packing IPQA, Documentation, Equipment Qualification, Vendor Qualification, LAB QA and QMS – OSD Quality Assurance
Designation: Officer / Sr. Officer / Executive / Sr. Executive
Location: Moraiya, Ahmedabad.
Roles and Responsibilities
1. IPQA Manufacturing
- Permit line clearance by reviewing equipment cleaning, area cleaning, temperature, RH, preventive maintenance status, calibration validity, logbook review, BMR review up to last stage, presence of any remnants from previous product, tool parts, nut bolts, gasket, differential pressure etc.
- Perform In-process quality checking activity from Compression, Coating, Capsule filling and Inspection.
- Collect samples for QC analysis according to SOP at different stages like Granulation, Compression, Coating and Capsule filling.
- BMR Preparation and revision through collect MFC from Doc Cell and prepare draft copy of BMR according to batch size, lot size and area details provided by production department.
- Validation / Exhibit batch through collect samples as per protocol at different stages and Send the collected samples to QC department.
- Hold time study sampling by collect samples at each stage of processing for all new molecules and Send the samples to QC department based on the hold time study protocol.
2. IPQA Packing
- Perform line clearance for PM dispensing and perform documentation crosschecking, conveyer belt, check were, print and spect machine, aggregation machine, weighing balance, documents- BPR and logbook.
- In-process quality check at an interval of 2 hours which include; forming temperature, sealing temperature, machine speed, cutting, sealing, knurling, batch coding details, printed foil code verification, hologram quality and presence of hologram, cross verifying cartoons, strips, tablets, labels etc.
- Perform cleaning verification, document verification, Preventive maintenance status, instrument calibration status, change part, verification related to area.
- Perform product related verification which includes; primary packing material verification, stereo verification and coding detail verification.
- Issued material with requisition slip by checking product code, product name and artwork number.
- Perform camera challenge test at the beginning of the batch, end of the day/shift, start of the day/shift, end of the batch, power failure and machine breakdown.
- Perform leak test in various situations like; at a regular interval of 4 hours, temperature change in forming or sealing temperature, change in speed, machine breakdown, maintenance, power failure, foil roll change etc.
3. Equipment Qualification
- Preparation of a sampling plan for the optimization batch through collecting samples from the granulation, compression, capsule filling, and coating stages and sending them to QC for analysis and performing required documentation activities, like the utilization log and test request slip, and then compiling the data from the optimization batch performed under the validation stage for the process optimization report after the completion of the optimization batch and sending the report for review and approval.
- Prepare a process validation protocol and send it for review, approval, and authorization to concerned team members by Facilitate process validation training for production, QC, and IPQA through collecting samples from the granulation, compression, capsule filling, and coating stages and sending them to QC for analysis and Perform the required documentation activities, like the utilization log and test request slip, then compile data for each batch performed during the validation stage, prepare a process validation report after the completion of the three validation batches, and send the report for review and approval.
- Perform a factory acceptance test (FAT) at the vendor site as per the requirement shared by the QA head and prepare qualification documents like IQ, OQ, PQ, and SAT (Site Acceptance Test) by ensuring execution of IQ, OQ, PQ, and SAT as per the approved protocol.
4. Documentation – Doc Cell
- Issuance of Intimation Slip for Issuance of Documentation and Formats to user department and receive the same.
- Maintenance of Doc Cell which includes labelling of racks and files.
- Receipt of formats in Loose format reconciliation record in case of revision in Logbook, Specification MoA, Formats, Worksheet and SOPs
- In case of revision, retrieval of filled formats and destroy the balanced quantity of formats which are not filled.
- Retrieval and archival of Logbook, Specification MoA, Formats, Worksheet and SOPs as per the SOP.
- Receive master copy from user department and crosscheck the points; SOP no, Version no, Superseded no, formatting as per SOP for SOP and revision history.
- Make softcopy of the Master copy and store at appropriate location.
5. Lab QA
- Perform internal audits of the laboratory, including both technical and quality system audits.
- Perform and document corrective action, including follow-up monitoring to gauge the effectiveness of the corrective action.
- Review audit trials and analytical reports related to QA/QC procedures for analytical tests.
- To review and approve the investigation report, analytical documents, and investigation regarding OOS investigation and deviation, and to provide support for investigation report preparation.
- To review analytical reports, analytical results, calibration reports, and instrument qualification. to review the electronic data and verify the chromatograms and printouts in raw data given by the Q.C. department.
- Review of the specification, method of analysis, and work sheet for RM/PM, FG, and stability.
- Ensure timely closure of the OOS and incidents by maintaining the log of out-of-spec and investigating the out-of-spec, then finding out the appropriate root cause of the OOS and initiating the CAPA based on the investigation outcome by maintaining the compliance of CGMP within a plant. and risk assessment of CCN in coordination with the team.
- Review and verify the executed logbooks in terms of data integrity, GDP, and GLP practices.
- Inform the supervisors if any discrepancies or non-compliances are found.
- Evaluate and assign a weight to the non-compliance.
- Handling the non-compliance with applicable QMS documentation, like deviation or CAPA
- Evaluation and assessment of change control and risk assessment of CCN in coordination with the team.
7. Vendor Qualification
- Send the vendor questionnaire (VQ) to the new vendor and coordinate the finalizing audit date.
- Collect all mandatory documents like TSE (transmissible spongiform encephalopathy), BSE (bovine spongiform encephalopathy), environmental impurities, stability data, 3 lots of CoA, GMO (genetically modified organism), melamine certificate, etc., and declarations of GMP, Halal, etc. from the vendor.
- Review the shared documents and declarations and communicate with the vendor in case of any discrepancies.
- Conduct a manufacturing site audit and prepare an audit report.
- Share the audit report with the vendor and communicate observations within 15 days from the date of the audit.
- Review the response and CAPA received from the vendor based on the audit report.
- Based on the satisfactory compliance report and CAPA acceptable to company, close the audit and prepare the closing report.
Perks & Benefits
- Dynamic work environment
- Career development opportunities
- Work-life balance
- Free transportation
- Free insurance coverage for self, spouse, and kids
- Range of learning opportunities to help employees grow and thrive