Required Freshers or Experienced Bachelor's or master's biotechnology candidates for Quality Assurance - IPQA - DS Biologics.

CuraTeQ Biologics is  looking for passionate individuals to join QA Team. Be part of a growing team in the biologics industry. 

Quality Assurance - IPQA - DS Biologics.

Following is the brief description of the role:

1. Responsible for in process quality assurance for critical intermediate and drug substance manufacturing operation of Cell culture and microbial products and to ensure all aseptic practices

must be followed as defined in standard operating procedure

2. Responsible for area clearance for batch processing, online process

monitoring, ensuring process sampling and supporting manufacturing.

3. Responsible for dispensing of raw materials, packing and consumable for critical intermediate and Drug substance batch manufacturing and any trial study.

4. Review of master and execution documents like batch manufacturing records, process validation, cleaning validation, cleaning verification, hold time studies, study protocols, reports and review of risk assessments

5. Responsible for preparation and review of QA documents, Procedures (SOPs),

6. Responsible for review of CI and DS related documents and production procedures (SOPs)

7. Review of manual and electronic (e-BMR) executed batch record along with all the supporting documents and addressing of comments through QMS system in coordination with cross functional teams and keep ready for batch release

8. Review of QMS documents (Change controls, Deviations, CAPA, OOS, OOT, risk analysis and Breakdowns etc.) and vendor-related changes & BOM with appropriate supporting documents and evidence.

9. Ensure manufacturing facility compliance as per the current Good Manufacturing Practices and reference SOPs. Ensure equipment status, the PM, AMC and calibration /qualification during shop floor rounds.

10. Review of Cell bank related records (BMR and tests results), Monitoring of cell bank related activities like storage conditions, Issuance and reconciliation of vials etc.

11. Tracking of completed batches for disposition as required after ensuring QMS compliance and ensure any temporary change controls initiated for the batches /facility and assess the impact before release of batch to DP manufacturing.

12. preparation of Trend analysis and APQR preparation

13. Review of cross functional SOPS, MMR, BMR, PTD, TTD, study protocol/ reports and GxP documents on e-DMS.

14. To participate in internal audits and to face regulatory audits and to comply with audit observations.

Qualification & Experience: Bachelor's or master's degree in biotechnology.

Experience: 

0-4 years of experience.

How to Apply: 

Interested can share their CV on careers@curateqbio.com, hr.biologics@curateqbio.com, 

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